Multi-piece accommodating intraocular lenses and methods for making and using same

ABSTRACT

An accommodating intraocular lens (AIOL) for implantation within a capsular bag of a patient&#39;s eye comprises first and second components coupled together to define an inner fluid chamber and an outer fluid reservoir. The inner region of the AIOL provides optical power with one or more of the shaped fluid within the inner fluid chamber or the shape of the first or second components. The fluid reservoir comprises a bellows region with fold(s) extending circumferentially around an optical axis of the eye. The bellows engages the lens capsule, and a compliant fold region between the inner and outer bellows portions allows the profile of the AIOL to deflect when the eye accommodates for near vision. Fluid transfers between the inner fluid chamber and the outer fluid reservoir to provide optical power changes. A third lens component coupled to the first or second component provides additional optical power.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a continuation of International Patent ApplicationNo. PCT/US2017/068226, filed Dec. 22, 2017, which claims priority toU.S. Provisional Application No. 62/438,969, filed on Dec. 23, 2016,entitled “MULTI-PIECE ACCOMMODATING IOL,” U.S. Provisional ApplicationNo. 62/544,681, filed on Aug. 11, 2017, entitled “MULTI-PIECEACCOMMODATING IOL”, U.S. Provisional Application No. 62/549,333, filedon Aug. 23, 2017, entitled “MULTI-PIECE ACCOMMODATING IOL,” the contentsof which are hereby incorporated by reference in their entireties.

BACKGROUND

The present disclosure relates to medical devices and methods. Inparticular, the present disclosure relates to accommodating intraocularlenses (hereinafter “AIOLs” or “AIOL” for singular).

Cataracts can affect a large percentage of the worldwide adultpopulation with clouding of the native crystalline lens and resultingloss of vision. Patients with cataracts can be treated by native lensremoval and surgical implantation of a synthetic intraocular lens (IOL).

Worldwide, there are millions of IOL implantation procedures performedannually. In the US, there are 3.5 million cataract proceduresperformed, while worldwide there are over 20 million annual proceduresperformed.

Although IOL implantation procedures can be effective at restoringvision, conventional IOLs have several drawbacks. For example, manyprior IOLs are not able to change focus as a natural lens would (knownas accommodation). Other drawbacks of conventional IOLs includerefractive errors that occur after implantation and require glasses forcorrecting distance vision, or in other cases the IOLs can be effectivein providing good far vision but patients need glasses for intermediateand near vision.

Several multi-focal IOLs have been developed to address these drawbacks,but they too can have drawbacks. For example, although multi-focal IOLsgenerally perform well for reading and distance vision, in at least someinstances such multi-focal IOLs may cause significant glare, halos, andvisual artifacts.

AIOLs have been proposed to provide accommodative optical power inresponse to the distance at which a patient views an object. However,such AIOLs are generally still in development and have differentdrawbacks. For example, prior AIOLs can provide insufficientaccommodation after implantation or produce suboptimal refractivecorrection of the eye. The amount of accommodation of the prior AIOLscan also decrease after implantation in at least some instances. Theprior AIOLs can also be too large to be inserted through a smallincision of the eye and may require the incision to be somewhat largerthan would be ideal. Also, at least some of the prior AIOLs can beunstable when placed in the eye, which can lead to incorrectaccommodation and other errors.

Improved implantable intraocular lenses that accommodate with thenatural mechanisms of controlling focusing of the eye that overcome atleast some of the above deficiencies would be desirable. Ideally, suchimproved AIOLs would provide increased amounts of accommodation whenimplanted, provide refractive stability, introduce few if anyperceptible visual artifacts, and allow the optical power of the eye tochange from far vision to near vision in response to the distance of theobject viewed by the patient.

SUMMARY

Embodiments of the present disclosure provide improved AIOLs and methodsfor making and using AIOLs. In many embodiments, the AIOLs include anaccommodating structure comprising an inner fluid chamber and an outerfluid reservoir disposed continuously circumferentially about the innerfluid chamber. The accommodating structure of the AIOLs can have aninner region, which is defined at least in part by the inner fluidchamber, that defines an optical structure having first and secondoptical components which provide optical power. The outer fluidreservoir may comprise a bellows fluidically coupled to the inner fluidchamber. The AIOLs provide optical power accommodation in one or moreways. For example, the bellows can have a compliant fold region thatdeflects when the eye accommodates for near vision and thereby transfersfluid between the outer fluid reservoir and the inner fluid chamber tochange the profile of the inner region and cause optical power changes.At the periphery of the inner fluid chamber, a plurality of protrusions,such as posts or bumps, may (1) provide a predetermined amount ofseparation between the first and second optical components and (2)define one or more fluid channels between the inner fluid chamber andthe outer fluid reservoir. Although the bellows can be configured inmany ways, in many embodiments the bellows extend continuously andcircumferentially around an optical axis of the AIOL, and one or morefolds of opposing sides of the bellows can extend toward each other in adirection similar to the optical axis. The folds of the bellows mayextend continuously and circumferentially substantially around theoptical axis, such as three hundred and sixty (360) degrees around theoptical axis.

Aspects of the present disclosure provide an AIOL for placement within alens capsule of a subject. The AIOL may comprise a first componenthaving the first optical component and a first bellows region, and asecond component having the second optical component and a secondbellows region. The second component is coupled to the first component.The inner fluid chamber can be formed between the first and secondoptical components. The outer fluid reservoir can be formed between thefirst bellows region and the second bellows region, and the outer fluidreservoir is in fluid communication with the inner fluid chamber. Inoperation, fluid transfers between the inner fluid chamber and the outerfluid reservoir in response to shape changes of the lens capsule therebychanging the shape of one or both of the first and second opticalcomponents for providing optical power changes to the AIOL.

Several embodiments of AIOLs also include a fixed lens coupled to theaccommodating structure. The fixed lens can provide a base power to theAIOL, and in several embodiments the accommodating structure may nothave a base power when in a relaxed condition (i.e., when no pressure isapplied to the outer fluid reservoir). However, in some embodiments boththe fixed lens and the accommodating structure may have the same ordifferent base powers. The fixed lens may be coupled to the posteriorside or the anterior side of the accommodating structure. In operation,the fixed lens can be selected to provide a desired base power of theAIOL, and the accommodating structure can then provide an adjustablepower to the AIOL in response to the natural mechanisms of controllingfocusing of the eye.

In several embodiments of the AIOLs, the fixed lens is coupled to theaccommodating structure to be positioned anteriorly with respect to thefirst and second optical components that provide the accommodativeoptical power. In such embodiments, the fixed lens is spaced anteriorlyapart from the first optical component to allow the first opticalcomponent to move anteriorly as fluid is driven from the outer fluidreservoir into the inner fluid chamber. Moreover, since the fixed lensis anterior of the first and second optical components, the fixed lenscan be coupled to the accommodating structure after the accommodatingstructure has been implanted in the native eye capsule. The fixed lenscan accordingly be selected to provide the desired refractiverequirements for a specific patient after the accommodating structurehas been implanted. This feature is useful because the opticalproperties of the accommodating structure may change after implantation,and it is the anterior orientation of the fixed lens that allows theappropriate fixed lens to be selected post-implantation based on theactual implanted optical properties of the accommodating structure.

Several embodiment of fixed lenses include additional features. Forexample, the fixed lens can include passages (e.g., holes or cutouts)that allow aqueous fluid to pass through the fixed lens, indexingfeatures for accurately positioning toric or other asymmetrical lenses,engagement features and/or skirts. The engagement features areconfigured to provide secure attachment of the fixed lens to theaccommodating structure, while also being detachable (e.g., a snap-fitor other type of interference fit). In several embodiments, the fixedlens has an optical portion that provides the optical properties to thefixed lens and a skirt extending posteriorly with respect to the opticalportion. The skirt spaces the fixed lens apart from the first opticalcomponent by a desired distance. The skirt can also enhance to opticalperformance of the accommodating structure. For example, the skirtconstrains the perimeter of the first optical component to preventdistortion that would otherwise occur as fluid moves to/from the innerfluid chamber. The skirt also defines the radius of the deformable areaof the first optical component such that a given amount fluid causesgreater accommodation than without the skirt. Additionally, the skirtprovides an inner wall that buttresses the outer fluid reservoir suchthat more fluid is pumped from the outer fluid reservoir into the innerfluid chamber in response to the natural focusing mechanism of the eyethan without the skirt.

Several embodiments of the present technology are directed to a kithaving an accommodating structure and a first fixed lens that has nooptical base power. The accommodating structure can be implanted intothe native eye capsule, and then the first fixed lens can be coupled tothe accommodating structure. The optical properties of the implantedaccommodating structure can then be assessed in situ with the firstfixed lens in place to determine the desired optical properties of thefixed lens. If the optical properties of the assembled accommodatingstructure and first fixed lens without a base power are appropriate,then the system can remain implanted without additional changes.However, if a different base power or some other optical property aredesired (e.g., toric or other asymmetrical optics), then the first fixedlens without a base power can be replaced with a second fixed lenshaving the desired optical properties based on the optical properties ofthe implanted accommodating portion with a fixed lens attached. The kitcan accordingly further include one or more second fixed lenses havingvarious based powers or other optical properties.

In many embodiments, the first component is glued to the secondcomponent at a joint. Additionally, bumps or other spacers can belocated on an inner surface of one or more of the first component or thesecond component to provide a gap between the first optical componentand the second optical component. The first component can be glued tothe second component at a joint extending circumferentially around thefirst component and the second component.

The first bellows region can extend continuously circumferentiallyaround the first optical structure, and the second bellows region canextend continuously circumferentially around the second opticalstructure.

The first bellows region may comprise one or more folds extendingcontinuously circumferentially around an optical axis of the firstoptical component, and the second bellows region may comprise one ormore folds extending continuously circumferentially around an opticalaxis of the second optical component.

The first bellows region may comprise one or more first folds extendinginwardly and continuously circumferentially around the first opticalcomponent, and the second bellows region may comprise one or more secondfolds extending inwardly and continuously circumferentially around thesecond optical component. Each of the first folds may extend toward acorresponding one of the second folds.

The first component may comprise a first annularly-shaped stiff couplingstructure extending circumferentially between the first opticalcomponent and the first bellows region to inhibit radial movement of thefirst optical component with radial movement of the first bellowsregion. The second component may comprise a second annularly-shapedstiff coupling structure extending circumferentially between the secondoptical component and the second bellows region to inhibit radialmovement of the second optical component with radial movement of thesecond bellows region. The first annularly-shaped structure may comprisea first radial thickness greater than a first thickness of the firstbellows region, and the second annularly-shaped structure may comprise asecond radial thickness greater than a second thickness of the secondbellows region.

The first component may comprise an anterior component, and the secondcomponent may comprise a posterior component. The first component maycomprise a first planar member, and the second component may comprise asecond planar member. One or more of the first and second components maycomprise a shell, such as a non-planar shell. One of the first or secondcomponents may comprise a planar member, and the other of the first orsecond components may comprise a plano-convex member shaped to providean optical power.

The fluid within the inner fluid chamber may shape the inner fluidchamber so as to provide an optical power. For example, the shape of thevolume of fluid in the inner fluid chamber may provide the optical powerof the accommodating structure. Optical power changes to the AIOL maycomprise a change to the optical power provided by the shape of thefluid within the inner fluid chamber. The change to the optical powerprovided by the shape of the fluid within the inner fluid chamber maycomprise a change to a shape of the inner fluid chamber. Optical powerchanges to the AIOL may comprise a change to a separation distancebetween the first optical component and the second optical component.For example, the separation distance can be the distance between thecenters of the first and second optical components measured along theoptical axis.

Protrusions peripheral to edges of the first and second opticalcomponents and radially inward from the bellows regions may overlap andmay be bonded with one another.

The outer fluid reservoir may comprise a bellows having a compliant foldregion between inner and outer bellows regions. For example, the outerfluid reservoir can have a fold that defines the fold region, which inturn separates the inner bellows region from the outer bellows region.The compliant fold region may be thinner than the inner and outerbellows regions. The inner fluid chamber may be deflectable in responseto deflection of the compliant fold region of the outer fluid reservoir.The compliant fold region may be thinner than the inner and outerbellows regions, which are located radially inward and radially outwardwith respect to the compliant fold region, respectively.

The AIOL may further comprise a plurality of protrusions, such as one ormore of bumps and posts, coupled to one or more of the first and secondcomponents. The protrusions can separate portions of the first andsecond components from one another. For example, the plurality ofprotrusions may be disposed along outer edges of the inner portions ofthe first and second optical components to separate the first and secondoptical components from each other. The plurality of protrusions maydefine a plurality of fluid channels between the inner fluid chamber andthe outer fluid reservoir, wherein each fluid channel is defined betweentwo adjacent protrusions.

The protrusions can be located between the bellows and the opticalcomponents to connect the first component to the second component. Theprotrusions can be located on one or more stiff coupling structures ofone or more of the first component and the second component to (a)provide the gap between the first optical component and the secondoptical component and (b) define a plurality of channels between thechamber and the reservoir to fluidically couple the reservoir to thechamber.

In many embodiments, the outer fluid reservoir comprises a compliantfold region between inner and outer bellows regions. The compliant foldregion can be thinner than the inner and outer bellows regions.

In many embodiments, protrusions are coupled to the first or secondcomponents, and the protrusions separate the first and second opticalcomponents from one another. The protrusions can be disposed between thebellows and the inner region, and the space between protrusions candefine fluid channels between the inner fluid chamber and the outerfluid reservoir. For example, each fluid channel is defined between twoadjacent posts.

One or more of the first or second components may comprise a polymericmaterial such as a PMMA copolymer. The polymeric material may be waterpermeable. The polymeric material may be hydrophilic and/or acombination of both hydrophilic and hydrophobic materials. For example,when the polymeric material is both hydrophilic and hydrophobiccomponents, the resulting polymeric material is predominantlyhydrophilic. Water within the lens capsule of the subject may transferinto or out of one or more of the inner fluid chamber or the outer fluidreservoir through the polymeric material to achieve an osmoticequilibrium when the AIOL is placed within the lens capsule. Thepolymeric material may be non-permeable to compounds having a molecularweight of greater than 40 kDa, for example. AIOLs in accordance with thepresent technology may further comprise the fluid within the inner fluidchamber. The fluid may comprise one or more of a solution, an oil, asilicone oil, a solution of dextran, a solution of high molecular weightdextran, or a solution of another high molecular weight compound.

In many embodiments, the first and second components are sufficientlyflexible to be folded into a reduced cross-section deliveryconfiguration. The reduced cross-section delivery configuration maycomprise one or more of folds or rolls of the intraocular lens around adelivery axis transverse to an optical axis of the accommodatingintraocular lens. AIOL systems and/or kits in accordance with thepresent technology may comprise a delivery tube or aperture, and thereduced cross-section delivery configuration may comprise theintraocular lens advanced into the delivery tube or aperture.

In many embodiments, the outer fluid reservoir comprises a hapticstructure to engage the lens capsule.

In many embodiments, the fluid within the inner fluid chamber has anindex of refraction greater than an index of refraction of an aqueoushumor of the eye of about 1.336.

In many embodiments, the first or second optical components provide nooptical power without a fluid in the inner fluid chamber. In manyembodiments, the fluid within the inner fluid chamber provides opticalpower.

In many embodiments, the first and second components are bonded to oneanother.

In many embodiments, both of the first and second components comprisethe same polymer material, and the first and second components arebonded with a prepolymer of the polymer material.

In many embodiments one or more of the first component or the secondcomponent is directly fabricated, such as by three-dimensional (3D)printing.

In many embodiments, the first component and the second component aredirectly fabricated together and comprise a single piece.

In many embodiments, the first component and the second component aremolded separately and bonded together.

In many embodiments, the first component and the second component arelathed separately and bonded together.

In many embodiments, the first component and the second component arebonded together at protrusions extending between the first component andthe second component.

In many embodiments, the first component comprises a first fabricatedpart and the second component comprises a second fabricated part.

Aspects of the present disclosure provide a method of providingaccommodation to an eye of a subject. A varying compressive force fromthe lens capsule may be received by the outer fluid reservoir of theaccommodating intraocular lens placed within a lens capsule of the eye.A fluid may be urged between the outer fluid reservoir and the innerfluid chamber of the AIOL in response to received varying compressiveforce. The outer fluid reservoir can be a bellows comprising a foldextending continuously circumferentially around an optical axis of theintraocular lens. One or more of a size or shape of the inner fluidchamber may be changed in response to the fluid urged into or out of theinner fluid chamber to change an optical power of the accommodatingintraocular lens.

In many embodiments, inner and outer bellows regions are in fluidcommunication with one another and the inner fluid chamber. One or moreof the bellows regions can be annular, elliptical, and/or rotationallysymmetric in shape.

In many embodiments, the outer fluid reservoir comprises a hapticstructure to engage the lens capsule.

In many embodiments, changing one or more of the size or shape of theinner fluid chamber comprises changing a separation distance betweenportions of first and second optical components.

In many embodiments, changing one or more of the size or shape of theinner fluid chamber comprises changing a radius of curvature of one ormore of the first or second optical components which define the innerfluid chamber.

In many embodiments, AIOLs comprise first and second optical componentswhich define the inner fluid chamber, and one or more of the first orsecond optical components comprises a plano-convex member shaped toprovide a minimum optical power to the accommodating intraocular lens.In other embodiments, at least one of the first and second opticalcomponents is a lens having an optical power comprising any suitablelens shape that produces an optical power.

In many embodiments, the inner fluid chamber contains a fluid thereinsuch that the pressure of the fluid shapes the inner fluid chamber. Theresulting shape of the fluid provides the optical power to theaccommodating intraocular lens.

In many embodiments, increasing the varying compressive force urgesfluid into the inner fluid chamber from the outer fluid reservoir.

Embodiments of the present disclosure provide improved AIOLs and methodsfor making and using AIOLs. Many embodiments of AIOLs in accordance withthe present technology comprise an optical structure comprising a stiffmember and a deflectable member (e.g., a deformable member) coupled to ahaptic structure. The stiff member and the deflectable member cansubstantially define an inner fluid chamber of the AIOL. The inner fluidchamber of the AIOL can be filled with a fluid having an index ofrefraction greater than the aqueous humor of the eye such that thedeflectable member defines a convexly curved surface of the volume ofthe fluid in order to provide a fluid lens having adjustable opticalpower. The deflectable member and stiff member may be coupled to thehaptic structure in order to deflect the profile of the deflectablemember to a convexly curved profile when the eye accommodates for nearvision.

In many embodiments, the stiff member comprises a lens such as aplano-convex lens having an optical power configured to treat far visionof the patient. When the eye accommodates, the deflectable portionprovides additional optical power for near vision. In many embodiments,the diameter of the lens of the stiff member corresponds to the diameterof the inner portion of the deflectable member, such that the diameterof the lens of the stiff member is sized smaller than the outer portionof the deflectable member, in order to decrease the thickness profile ofthe AIOL when inserted into the eye.

In many embodiments, an accommodating IOL comprises a first componentand a second component each composed of a polymer, and an adhesivecomprising the polymer. Alternatively, or in combination, the firstcomponent can be affixed to the second component with mechanicalcoupling such as interlocking joints, threads, mounts or fasteners. Inmany embodiments, the polymer can be hydrated and swells with hydration,such that the first component, the second component, and the adhesiveswell together (e.g., at the same or substantially similar rate). Byswelling together, stresses among the first component, the secondcomponent, and the adhesive can be inhibited substantially. Also, thehydratable adhesive allows the first and second components to bemachined when they are less than fully hydrated and stiff (i.e., a stiffconfiguration) prior to adhering of the components together. The stiffconfiguration may comprise a less than fully hydrated polymer, such as asubstantially dry polymer. The components can be bonded together in thesubstantially stiff configuration to facilitate handling duringmanufacturing, and subsequently hydrated such that the components bondedby the adhesive comprise a soft hydrated configuration for insertioninto the eye. The adhesive comprising the polymer can bond the first andsecond lens components together with chemical bonds similar to thepolymer material itself in order to provide increased strength. Forexample, the “chemical bonds” can be the same cross links as those ofthe polymer material.

In another aspect of the disclosure, an intraocular lens is provided.The intraocular lens may comprise an optical structure having an opticalpower and comprising a deflectable member, a stiff member, and a fluidchamber defined at least partially between the deflectable member andthe stiff member. The intraocular lens may comprise a haptic structurecoupled to a peripheral region of the stiff member and comprising ananterior element, a posterior element, and a fluid reservoir defined atleast partially between the anterior element and the posterior element.The fluid reservoir may be in fluid communication with the fluid chamberwith one or more channels. In many embodiments, a volume of the fluidchamber may increase in response to the decrease in the volume of thefluid reservoir to change the optical power. A shape of the fluid-filledchamber may change in response to the increase in the volume of the lensfluid chamber to change the optical power.

In another aspect of the disclosure, an intraocular lens comprises anoptical structure comprising a posterior member, an anterior member, anda fluid-filled chamber between the posterior and anterior members. Theintraocular lens may include a haptic structure interlocking peripheralregions of the posterior and anterior members to inhibit leakage of afluid into and out of the fluid-filled haptic chamber. In manyembodiments, the interlocking regions may comprise a fluid tight seal toinhibit leakage of the fluid. The haptic structure may have a first sidehaving one or more male members and a second side having one or morefemale members. The one or more male members may pass through theperipheral regions of the posterior and anterior members to be receivedby the one or more female members to interlock the peripheral regions.The peripheral regions of the posterior and anterior members may haveone or more apertures through which the one or more members passthrough. The peripheral regions of one or more of the posterior oranterior members may have one or more male members to be received by oneor more female members of the haptic structure to interlock theperipheral regions. The interlocking of the peripheral regions of theposterior and anterior members by the haptic structure may be maintainedas the intraocular lens is deformed to change an optical power of theoptical structure and/or folded or rolled into a delivery configuration.

In yet another aspect of the disclosure, an AIOL comprises an opticalstructure comprising a posterior member, an anterior member, and afluid-filled chamber between the posterior and anterior membersproviding an optical power. The intraocular lens may comprise a hapticstructure coupled to the optical structure. One or more of a shape orvolume of the fluid-filled chamber may be configured to change inresponse to a radial force exerted on the haptic structure. The changeof one or more of the shape or volume of the fluid-filled chamber maychange the optical power of the fluid-filled chamber while leavingoptical powers provided by the posterior and anterior memberssubstantially unchanged.

In another aspect of the disclosure, a method of providing accommodationto an eye of the patient is provided. The method may comprise placing anAIOL within a lens capsule of the eye. One or more of a shape or volumeof a fluid-filled chamber of the intraocular lens may be changed tochange an optical power of the fluid-filled chamber while leavingoptical powers provided by the posterior and anterior memberssubstantially unchanged.

In many embodiments, the deflectable optical members as described hereinhave the advantage of deflecting while substantially maintaining athickness of the optical member in order to inhibit optical aberrationswhen the member deflects.

An aspect of the disclosure provides an intraocular lens forimplantation within a lens capsule of a patient's eye. The intraocularlens may comprise an optical structure and a haptic structure. Theoptical structure may have a peripheral portion and may comprise aplanar member, a plano-convex member coupled to the planar member at theperipheral portion, and a fluid optical element defined between theplanar member and the plano-convex member. The fluid optical element maycomprise a fluid having a refractive index similar to either or both thematerials comprising the planar member and the plano-convex member. Forexample, the refractive index of the fluid can be greater than thenative aqueous fluid of the eye. The haptic structure may couple theplanar member and the plano-convex member at the peripheral portion ofthe optical structure. The haptic structure may comprise a fluidreservoir in fluid communication with the fluid optical element and aperipheral structure for interfacing to the lens capsule. Shape changesof the lens capsule may cause one or more of volume or shape changes tothe fluid optical element in correspondence to deformations of theplanar member to modify the optical power of the fluid optical element.For example, shape changes of the lens capsule may cause the hapticstructure to exert a mechanical force on the planar member to deform themember and correspondingly modify the optical power of the fluid opticalelement. Such deformations of the planar member may in some cases causeno change to the optical power of the planar member, the plano-convexmember, or both (i.e., the change in optical power may solely beprovided by one or more of the shape or volume changes to the fluidoptical element and optionally changes to the anterior-posteriorposition of the intraocular lens within the lens capsule.)

A force imposed on the haptic fluid reservoir may deform the hapticfluid reservoir to modify the optical power of the fluid opticalelement. The force imposed on the haptic fluid reservoir may transferfluid into or out of the fluid optical element from the haptic fluidreservoir to reversibly deform the haptic fluid reservoir.

In many embodiments, volume changes to the fluid optical element areprovided by a fluid contained in the haptic fluid reservoir. In manyembodiments, fluid transfer into or out of the fluid optical elementleaves the plano-convex member un-deformed. The plano-convex member maycomprise a stiff member and the planar member may comprise a deflectablemember. In these embodiments, the fluid optical element may provide amajority of the optical power of the intraocular lens. Fluid within thefluid optical element and within the fluid reservoir of the hapticstructure may have a refractive index of greater than or equal to 1.33.

The fluid within the fluid optical element and the fluid reservoir ofthe haptic structure may comprise oil such as a silicone oil or asolution such as a high molecular weight dextran. The fluid can beprovided with a suitable index of refraction. For example, the highmolecular weight dextran configured with a suitable index of refractiongreater than 1.33 and an osmolality similar to the aqueous humor of theeye. The high molecular weight dextran may also have a mean molecularweight of at least 40 kDa, and the mean molecular weight can be within arange from about 40 kDa to about 2000 kDa, with intermediate rangeshaving upper and lower values defined with any of 40 kDa, 70 kDa, 100kDa, 1000 kDa, or 2000 kDa. The high molecular weight dextran maycomprise a distribution of molecular weights, and the distribution ofmolecular weights can be narrow or broad. As the index of refraction canbe determined based on the weight of dextran per volume and theosmolality by the number of solute particles per volume, the meanmolecular weight and amount of dextran can be used to configure thedextran solution with the appropriate index of refraction andosmolality.

In many embodiments, the haptic structure is configured to orient theintraocular lens in place within the lens capsule of the patient's eye.In many embodiments, the haptic structure comprises an anterior hapticstructure and a posterior haptic structure that are coupled together todefine the outer fluid reservoir therebetween. In many embodiments, thehaptic structure comprises an annular structure coupled to theperipheral region of the optical structure. The haptic structure maycomprise a plurality of tab structures coupled to and distributed overthe peripheral portion of the optical structure.

The peripheral portion may comprise a plurality of apertures and thehaptic structure may be coupled to the peripheral portion through theplurality of apertures. The plurality of apertures may be orientedsubstantially parallel to the optical axis of the intraocular lens.Alternatively, or in combination, the plurality of apertures may beoriented transverse to the optical axis of the intraocular lens. Thehaptic structure may comprise one or more posts or other structures forplacement through the plurality of apertures of the peripheral portionof the optical structure to couple the haptic structure to theperipheral portion. Alternatively, or in combination, the opticalstructure may comprise posts for mating with structures such asapertures in the haptic structures.

The AIOLs may be sufficiently flexible to be folded into a reducedcross-section delivery configuration. The reduced cross-section deliveryconfiguration of the AIOLs may be attained by folding or rolling theAIOLs around a delivery axis normal to an optical axis AIOLs.Alternatively, or in combination, the reduced cross-section deliveryconfiguration of the AIOLs may be attained by advancing the intraocularlens through a delivery tube or aperture.

In many embodiments, the planar member is posterior of the plano-convexmember when the AIOL is placed in the lens capsule.

Another aspect of the disclosure provides a method of providingaccommodation in an eye of a patient. First, an AIOL is provided. Theprovided AIOL may comprise an optical structure and a haptic structure,and the optical structure can have a peripheral portion. The opticalstructure may comprise a first optical element (e.g., a planar member),a second optical element (e.g., a plano-convex member) coupled to thefirst optical element at the peripheral portion, and a fluid opticalelement defined between the first and second optical elements. The fluidoptical element may comprise a fluid having a refractive index similarto either or both the materials of the first and second opticalelements. The fluid optical element may have an optical power. Thehaptic structure may couple the first and second optical elementstogether at the peripheral portion of the optical structure. The hapticstructure may comprise a fluid reservoir in fluid communication with thefluid optical element and a peripheral structure for interfacing to thelens capsule. Second, the AIOL may be folded into a reduced profileconfiguration. Third, the folded AIOL may be implanted into a lenscapsule of the patient's eye. The folded AIOL reverts into a workingconfiguration from the reduced profile configuration when implanted intothe lens capsule. Fourth, one or more of the optical structure or thehaptic structure may be actuated to cause one or more of volume or shapechanges to the fluid optical element in correspondence to deformationsin the planar member to modify the optical power of the fluid opticalelement.

One or more of the optical or haptic structure may be actuated byradially directing a force on the haptic structure to deform the planarmember to modify the optical power of the fluid optical element. Thehaptic peripheral structure may be stiffly coupled to the substantiallyplanar member of the optical structure. The change in optical power ofthe fluid optical element may be accompanied by a transfer of fluid intoor out of the fluid optical element from the fluid reservoir of thehaptic structure. Transfer of fluid into or out of the fluid opticalelement from the haptic fluid chamber may deflect the planar memberwhile leaving the plano-convex member un-deflected. In alternativeembodiments, transfer of fluid into or out of the fluid optical elementfrom the haptic fluid chamber may deflect the planar member andoptionally also the plano-convex member.

One or more of the optical structure and the haptic structure may beactuated by imposing a force on the haptic fluid reservoir to reversiblydeform the haptic fluid reservoir to modify the optical power of thefluid optical element.

In many embodiments, the peripheral portion of the optical structurecomprises a plurality of apertures and the haptic structure couples theposterior and anterior members together at the peripheral portion of theoptical structure through the plurality of apertures. The hapticstructure coupled to the plurality of apertures of the peripheralportion may maintain the substantially planar and plano-convex memberscoupled together as the intraocular lens is folded and during functionor operation of the intraocular lens. The plurality of apertures may beoriented substantially parallel to the optical axis of the intraocularlens. The plurality of apertures may be oriented transverse to theoptical axis of the intraocular lens. The haptic structure may compriseone or more posts for placement through the plurality of apertures tocouple the haptic structure to the peripheral region. Alternatively, orin combination, the peripheral portion of the optical structure may haveone or more apertures through which one or more posts of the hapticstructure can pass through to couple the optical and haptic structurestogether.

The AIOLs may have reduced profile configuration by folding or rollingthe AIOLs around a delivery axis normal to an optical axis of the lens.Alternatively, or in combination, the AIOLs may be folded into thereduced profile configuration by advancing the intraocular lens througha delivery tube or aperture.

The folded AIOLs may be implanted into the lens capsule by allowing thefluid within the lens fluid chamber to reach an osmotic equilibrium withfluid present in the lens capsule. One or more of the planar orplano-convex members may be water permeable to allow the osmoticequilibrium to be reached. In many embodiments, the porous posterior oranterior member is non-permeable to compounds having a molecular weightof greater than 40 kDa.

In many embodiments, one or more of the planar or plano-convex membershas substantially no optical power.

In many embodiments, the planar member is posterior of the plano-convexmember when the intraocular lens is placed in the lens capsule.

In another aspect, embodiments provide a method of manufacturing AIOLsby providing a first component comprising a polymer, and a secondcomponent comprising the same polymer. The first component is bonded tothe second component with an adhesive. The adhesive may comprise aprepolymer of the polymer of the first and second components. Forexample, the prepolymer can be any individual species of the polymerscomprising the first and second components, or any combination thereof,as monomers, short chain multimers, and/or partially polymerized.

In many embodiments, the prepolymer is cured to bond the first componentto the second component with the polymer extending between the firstcomponent and the second component.

In many embodiments, the first component and the second component eachcomprise a stiff configuration when the first component is bonded to thesecond component with the polymer extending between the first componentand the second component.

In many embodiments, the first component, the second component and thecured adhesive are hydrated to provide a hydrated, soft accommodatingintraocular lens.

In many embodiments, hydrating the first component, the second componentand the adhesive comprises fully hydrating the polymer of each of thefirst and second components and the adhesive to an amount of hydrationcorresponding to an amount of hydration of the polymer when implanted.In several embodiments, the adhesive is indistinguishable from the basepolymer upon being cured.

In many embodiments, each of the first component, the second componentand the cured adhesive each comprise a first configuration prior tohydration (e.g., stiff configuration) and second configuration whenhydrated (e.g., soft configuration), and wherein each of the firstcomponent, the second component, and the cured adhesive expand asubstantially similar amount from the first configuration to the secondconfiguration in order to inhibit stress at interfaces between theadhesive and the first and second components.

Many embodiments further comprise providing the polymer material andshaping the first component and the second component from the polymermaterial.

In many embodiments, the first component and the second component areeach turned on a lathe when stiff in order to shape the first componentand the second component.

In many embodiments, the first component and the second component aremolded.

In many embodiments, the prepolymer comprises one or more of a monomer,an oligomer, a partially cured monomer, particles, or nano-particles ofthe polymer.

In many embodiments, the first component comprises a disc shapedstructure and the second component comprises a disc shaped structure andwherein the first component and the second component define a chamberwith the disc shaped structures on opposite sides of the chamber whenbonded together.

In many embodiments, one of the first component or the second componentcomprises a groove sized and shaped to receive the other of the first orsecond component and wherein the adhesive is placed on the groove.

In many embodiments, one or more of the first component or the secondcomponent comprises an annular structure extending between a first discstructure and a second disc structure in order to separate the firstdisc structure from the second disc structure and define a side wall ofthe chamber.

In another aspect, AIOLs comprise a first component, a second component,and an adhesive. The first component comprises a polymer material. Thesecond component comprises the same polymer material. A cured adhesivecomprises the polymer between at least a portion of the first componentand the second component in order to bond the first component to thesecond component and define a chamber.

In many embodiments, the inner fluid chamber comprises an opticalelement. Many embodiments further comprise a fluid within the innerfluid chamber having an index of refraction greater than an index ofrefraction of an aqueous humor of an eye of about 1.336, and wherein oneor more of the first component or the second component is configured todeform to increase an optical power of the accommodating intraocularlens.

Many embodiments further comprise one or more haptics to engage a wallof a capsular bag of the eye and increase curvature of one or more ofthe first component or the second component in response to the walland/or the perimeter at the zonule attachment of the capsular bagcontracting in order to increase optical power of the accommodatingintraocular lens.

Many embodiments further comprise a fluid, the fluid comprising one ormore of a solution, an oil, a silicone, oil, a solution of highmolecular weight molecules, or high molecular weight dextran.

Many embodiments further comprise a seam comprising the adhesive, theseam extending circumferentially along at least a portion of the firstcomponent and the second component.

In many embodiments, the first component comprises a first disc shapedstructure and the second component comprises a second disc shapedstructure. An annular structure can extend between the first disc shapedstructure and the second disc shaped structure to separate the firstdisc shaped structure from the second disc shaped structure and definethe inner fluid chamber.

In many embodiments, the intraocular lens comprises a stiffconfiguration prior to implantation and a soft configuration whenimplanted.

In many embodiments, the first component comprises a first disc shapedoptical structure comprising one or more of a lens, a meniscus, ameniscus lens, or a flat plate, and wherein the second componentcomprises a second disc shaped optical structure comprising one or moreof a lens, a meniscus, a meniscus lens, or a flat plate.

Yet another aspect of the disclosure provides AIOLs for implantationwithin a lens capsule of a patient's eye. The AIOLs may comprise anoptical structure and a haptic structure. The optical structure may havea peripheral portion and may comprise a posterior member, an anteriormember coupled to the posterior member at the peripheral portion, and afluid optical element defined between the posterior and anteriormembers. The fluid optical element may comprise a fluid having arefractive index similar to either or both the materials comprising theposterior member and the anterior member. The fluid optical element mayhave an optical power. The haptic structure may couple the posterior andanterior members at the peripheral portion of the optical structure. Thehaptic structure may comprise a fluid reservoir in fluid communicationwith the fluid optical element and a peripheral structure forinterfacing to the lens capsule. Shape changes of the lens capsule maychange the volume or shape of the fluid optical element incorrespondence to deformations in one or more of the posterior oranterior members to modify the optical power of the fluid opticalelement. One or more of the posterior member or the anterior member ofthe optical structure may be permeable to water such that water presentin the lens capsule of the patient's eye may be capable of transferringinto or out of the fluid lens chamber there through to achieve anosmotic equilibrium with fluid present in the lens capsule when the AIOLis placed therein. The various features of the AIOLs may further beconfigured in many ways in accordance with the many embodimentsdisclosed herein.

In another aspect of the disclosure, an AIOL may comprise an opticalstructure having a fluid chamber and a material within the fluidchamber. The material may comprise a less than fully hydrated state. Aportion of the optical structure may be configured to provide water tothe fluid chamber and inhibit leakage of the material from the fluidchamber in order to fully hydrate the material and expand the fluidchamber when placed in the eye.

In yet another aspect of the disclosure, a method of implanting AIOLswithin a lens capsule of a patient's eye is provided. The method maycomprise advancing an AIOL comprising a less than fully hydratedconfiguration through an incision of the eye. Water from the lenscapsule may pass through at least a portion of the optical structure tofully hydrate the AIOL. In many embodiments, material within a fluidchamber of an optical structure of intraocular lens may be inhibitedfrom leakage from at least a portion of the optical structure whilewater from the lens capsule passes through to fully hydrate thematerial.

In several embodiments, the outer fluid reservoir and the inner fluidchamber are filled with a hydrophobic oil which inhibits or fullyprecludes the transfer of water into the inner fluid chamber. Forexample, the hydrophobic oils can be selected from any of the following:HYDROCARBON (HYDROBRITE 550), POLYDIMETHYLSILOXANE,POLYOCTYLMETHYLSILOXANE, POLY(2-PHENYLPROPYL)METHYLSILOXANE,PHENYLMETHYLSILOXANE OLIGOMER, PHENYLMETHYLSILOXANE-DIMETHYLSILOXANECOPOLYMER, DIPHENYLSILOXANE-DIMETHYLSILOXANE COPOLYMERS,PHENYLMETHYLSILOXANE-DIMETHYLSILOXANE COPOLYMERS,1,1,3,5,5-PENTAPHENYL-1,3,5. This fluid is applicable to any AIOLdescribed herein.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

Features of the present technology are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present technology will be obtained by reference tothe following detailed description that sets forth illustrativeembodiments, in which the principles of the invention are utilized, andthe accompanying drawings of which:

FIG. 1 shows a cross-sectional view of a fluid filled accommodating lenssystem comprising a bellows structure in accordance with embodiments;

FIG. 2 shows a cross-sectional view of an alternate accommodating lenssystem in accordance with embodiments;

FIG. 3 shows a cross-sectional view of an alternate fluid filledaccommodating lens system in accordance with embodiments;

FIGS. 4A-4C illustrate AIOL assembly 400 comprising four main parts, inaccordance with embodiments;

FIG. 5 is a completed AIOL assembly 500, an alternate embodiment to AIOL400;

FIGS. 6A-6C illustrate AIOL 600 comprising three main parts, inaccordance with embodiments; and

FIGS. 7A-7B illustrate AIOL 700 comprising three main parts, inaccordance with embodiments.

FIG. 8 depicts an AIOL lens system comprising multiple square-shapedannular regions.

FIGS. 9A-9C illustrate accommodating intraocular lens systems 900incorporating additional features to enhance performance.

FIGS. 10A-10C illustrate accommodating intraocular lens systems 1000incorporating additional features to enhance performance.

FIG. 11 depicts AIOL delivery device 1100 with a properly oriented lenssystem entering the injector tip for delivery.

FIGS. 12A-12C present an AIOL embodiment comprising a mid-bellowsstabilizing feature.

FIGS. 13A-13J embody two different flow features, one defined by outerflow-throughs and the other defined by inner flow-throughs.

FIGS. 14A-14E present an alternate design for a fixed lens assembly.

FIGS. 15A-15D present an alternate design for a fixed lens assembly.

FIGS. 16A-16B illustrate a structural element comprising one or morethickened portions on an inner wall, shaped to interface with one ormore passages.

FIGS. 17A-17G illustrate three outer flow-throughs to provide enhancedaccess for a suction tool to remove OVD from the posterior space betweenthe capsule and the posterior surfaces of the AIOL.

FIGS. 18A-18D illustrate accommodating intraocular lens 1800incorporating features to enhance performance.

DETAILED DESCRIPTION

Accommodating intraocular lenses (AIOLs) as described herein can be usedto provide improved vision, and can be combined with one or more of manyknown surgical procedures and apparatus, such as cataract surgery andintra-ocular lens inserters. The optical structures of the AIOLs arewell suited for use with commercially available IOL power calculationsbased on biometry of the eye, and can be used to provide improvedvision. In many embodiments, a physician can insert an AIOL as describedherein in a manner similar to prior non-accommodating IOLs such that theAIOLs as described herein can be readily used.

The present disclosure relates to devices, methods, and systemsassociated with AIOLs. Some embodiments will comprise a central opticalstructure comprised of at least one deformable optical component (e.g.,an optical element) spaced apart along an optical axis, such as by asupport structure concentric with the optical axis of the lenses.Several embodiments include a first optical component and a secondoptical component, and at least one of the first and second opticalcomponents can be deformable while the other of the first and secondoptical components can be deformable or rigid. The volume bounded by thefirst and second optical components, and optionally the lens supportstructure, may define a fluid chamber that can be filled with an ionicsolution, such as saline, or non-ionic solutions such as dextran orsilicone oil. The first and second optical components may instead bebounded by one or more haptic structures, and the haptic structures maydefine an outer fluid reservoir filled with a fluid and arranged in aplane normal to the optical axis of the first and second opticalcomponents. The fluid in the outer fluid reservoir of the hapticstructures can be in fluid communication with the fluid in the innerfluid chamber bounded by the optical structure. The transfer of fluidbetween the haptic structures and the inner fluid chamber of the opticalstructure can change the accommodating power of the fluid within theinner fluid chamber by deforming one or both of the first and secondoptical components. The improved AIOL system may additionally compriseany combination of the features described herein.

The optical components and some of the support structures describedherein will typically be fabricated from a hydrophilic material that isoptically clear when hydrated, swells on hydration by more than 10%, andaccommodates strain levels of greater than 100% when hydrated. Thematerial can be purchased as small disks and rods. For example, thehydrophilic material may comprise a copolymer of hydroxyethylmethacrylate (HEMA) and methyl methacrylate (MMA) such as CI18, CI21, orCI26 produced by Contamac Ltd. of the UK. The material may alternatelybe comprised of a co-polymer of HEMA and EOEMA such as apoly(2-ethyloxyethyl methacrylate, which can be purchased as a BENZ IOL25 or a BENZ IOL 25 UVX from Benz Research & Development, 6447 ParklandDr., Sarasota, Fla. 34243 United States. These materials are alsodenoted as PMMA herein, and as used herein PMMA refers to a polymercomprising PMMA or a copolymer comprising PMMA, such as one or more ofPMMA polymer (also referred to herein as “poly(methyl methacrylate)”),or a copolymer of HEMA and PMMA such as p(HEMA-co-MMA), for example. Asused herein p(HEMA-co-MMA) refers to a copolymer of HEMA and PMMA andcan also be referred to as p(HEMA-MMA

The copolymer may comprise one or more of a block copolymer (PPPP-HHHH),alternating copolymer (PHPHPHPH), statistical or random copolymer(PHPPHPHH), a star copolymer, a brush copolymer, or a graft copolymer,for example, where “P” identifies “MMA” and “H” identifies “HEMA”, forexample.

In some embodiments, components of a hydrogel AIOL may be fabricated by3D printing, including but not limited to any of the following common 3Dprinting processes: Stereolithography (SLA), Inkjet material jetting(IMJ), Digital Light Processing (DLP), Selective Laser Sintering (SLS),Fused Deposition Modeling, or Fused Filament Fabrication (FDM/FFF).Methods such as SLA, IMJ, and DLP may be particularly suited to thefabrication of AIOL elements comprised of hydrogels such as PMMAs andcopolymers such as HEMA. In such embodiments, the starting material maybe monomer or oligomer precursors, or combinations thereof, of thehydrogel polymer. One such polymer useful in the fabrication of AIOLsherein described may comprise pHEMA, in which the polymerizationreaction can be photo initiated by a UV source of appropriate wavelengthand duration. In some such embodiments, photo initiation may be furtherenhanced by the addition of a photoinitiator compound mixed with themonomers used for printing. Such photoinitiators can release additionalfree radicals on illumination thereby increasing the rate of thepolymerization reactions. A selection of photoinitiators is listedbelow.

In some embodiments, a complete AIOL may be fabricated by a 3D printingprocess and the un-polymerized materials on the inside of the opticalstructure can be removed after completion of the build. Alternatively,or in combination, the un-polymerized materials within the opticalstructure may be treated such that reactive end groups are renderednonreactive to prevent further polymerization. In other embodiments, theAIOL structures may be fabricated as subcomponents for later assembly asdescribed elsewhere herein for machined parts.

As used herein, a positive curvature of an outer surface encompasses aconvex curvature and a negative curvature of an outer surfaceencompasses a concave curvature.

As used herein, like reference numerals refer to like structures. Inmany embodiments as described herein, the reference numerals comprisethree or four digits in which the first one or two digits refer to thenumber of the drawing and the last two digits refer to like structuresamong figures having different numbers. For example, the referencenumerals 105 and 1205 refer to similar deflectable members of FIG. 1 andFIG. 12, respectively. A person of ordinary skill in the art willrecognize that text describing a structure of one figure may apply to asimilar structure of any other figure as provided herein.

In some embodiments, the intraocular lens, lens system and/or othercomponents defining the fluid chamber of the optical structure arefilled with a water-based clear fluid with a refractive index higherthan water to increase the optical power of the system. The highrefractive index of such fluids may be caused by the presence ofsolutes, such as large molecules incapable of crossing the chamberdefining components. Examples of suitable large molecules includedextran, with exemplary molecular weights of <40 kD, <70 kD, <500 kD,and <1000 kD. Further examples of suitable solutes include sugarmolecules. The solutes and water may compose a diluted solution havingan osmolality that, for example, causes water to move into or out of thechamber to achieve an osmotic equilibrium volume. The osmoticequilibrium volume can be adequate to produce the appropriate opticalpower in the system to the desired power for the patient.

The soft material of the optical structures of the AIOL can be shaped inone or more of many ways, and may comprise machined components, moldedcomponents, or combinations thereof, for example.

AIOLs in accordance with the present technology can have a reduceddelivery cross-section. The reduced delivery cross-section can befacilitated by an optical structure capable of translating from adelivery configuration to an operational configuration. The opticalstructure may have a small dimension along the optical axis in thedelivery configuration and larger dimension along the optical axis inoperational configuration. Also, a lens support structure can beconfigured to maintain the distance between the peripheries of the twooptical components in the operational configuration and to allow fluidto pass between the haptic structures and the fluid volume bounded bythe optical structure in either configuration.

The delivery cross-section may be attained by folding or rolling an AIOLaround a delivery axis normal to the optical axis. The deliverycross-section may be measured as the largest dimension in the deliveryconfiguration measured in a plane normal to the delivery axis. Deliverycross-sections attainable for several embodiments of the AIOLs disclosedherein may be less than 4.5 mm, and preferably less than 2.5 mm. Inalternate embodiments, the delivery cross-section can be attained byforcing the AIOL through a tube or delivery aperture. Such a tube may beconical in cross-section such that the AIOL may be compressed as itprogresses down the tube. The distal end may be sized to interface withan incision in the eye. Delivery may be facilitated by syringes orplungers.

The intraocular lens system may be comprised of at least two PMMAoptical components where PMMA denotes a compound comprising one or moreof poly(methyl methacrylate) (PMMA), poly(hydroxyethyl methacrylate)(PHEMA), (Hydroxyethyl)methacrylate (HEMA), or Methyl methacrylate(MMA), for example. The lens system may include other elements comprisedof any or any combination of the following materials: NiTi,polyurethane, hydrophilic PMMA, photo-activated polymers, precursors toPMMA, Ethylene glycol dimethacrylate (EGDMA), silicones, siliconecopolymers, among others.

One or more of the optical components, such as a substantially planarmember or a plano-convex member, may comprise a polymeric material. Thepolymeric material may comprise a material, for example available fromContamac Ltd. of the UK or Vista Optics Ltd. of the UK. For example, thePMMA copolymer may be selected from the list comprising a Definitive 50material, a Definitive 65 material, a Definitive 74 material, a FilconV3 material, a Filcon V4 material, a Filcon V5 material, an OptimumClassic material, an Optimum Comfort material, an Optimum Extramaterial, an Optimum Extra 16 material, an Optimum Extra 18.25 mmmaterial, an Optimum Extra 19 mm material, an Optimum Extra 21 mmmaterial, an Optimum Extreme material, an F2 material, an F2 Lowmaterial, an F2 Mid material, an F2 High material, a Focon III 2material, a Focon III 3 material, a Focon III 4 material, a Hybrid FSmaterial, a Contaflex GM Advance material, a Contaflex GM Advance 49%material, a Contaflex GM Advance 58% material, a Filcon I 2 material, aFilcon II 2 material, a Contaflex GM3 49% material, a Contaflex GM3 58%material, a Contaflex material, a Contaflex 58% material, a Contaflex67% material, a Contaflex 75% material, a Polymacon 38% material, aHefilcon 45% material, a Methafilcon 55% material, a Filcon II material,a Filcon IV 2 material, an H156 material, a PMMA material, a CI26material, a CI26Y material, a CI18 material, and other variantsavailable from Contamac Ltd. of the UK and a Vistaflex GL 59 material, aHEMA/GMA material, an Advantage+ 49 material, an Advantage+ 59 material,a Filcon I 1 material, a Filcon 12 material, a VSO nVP material, anVP/MMA material, a VSO 60 material, a VSO 68 material, a VSO 75material, a Filcon II 1 material, a Filcon II 2 material, a VSO pHEMAmaterial, a pHEMA material, a HEMA material, a VSO 38 material, a VSO 42material, a VSO 50 material, a Vistaflex 67 Clear UV material, apolysiloxy-acrylate material, an AddVALUE Silicone Acrylate material, anAddVALUE 18 material, an AddVALUE 35 material, apoly-fluoro-silicon-acrylate material, an AddVALUE Fluor SiliconeAcrylate material, an AddVALUE 25 material, an AddVALUE 50 material, anAddVALUE 75 material, an AddVALUE 100 material, a Scleral Rigid GasPermeable material, a hydrophobic intraocular lens material, a VOPhobicClear Tg 16 material, a VOPhobic Yellow Tg 16 material, a hydrophilicintraocular lens material, a HEMA-MMA copolymer material, an IOSoftmaterial, an IOSoft clear material, an IOSoft yellow material, a PMMAmaterial, a Vistacryl CQ UV material, a Vistacryl XL blue material, aVistacryl CQ material, and other variants available from Vista OpticsLtd. of the UK. Often, the polymeric material may be water permeableand/or hydrophilic. Water present in the lens capsule of the patient'seye may transfer into or out of the fluid optical element through thepolymeric material to achieve an osmotic equilibrium with fluid presentin the lens capsule when the intraocular lens is placed therein. Thepolymeric material may be non-permeable to silicone oil. The polymericmaterial may be non-permeable to compounds having molecular weights ofgreater than 40 kDa.

In some embodiments, an AIOL in accordance with the present technologyis inserted into and interfaced with the natural capsule such that theinterface zones create a seal which forms a semi toroidal region ofcapsule. In operation, fluid transfer between the semi toroidal regionand the interior of the AIOL causes an accommodation change in the AIOL.In such embodiments, fluid such as saline may be injected into the semitoroidal region.

In some embodiments, the lens support structure and one opticalcomponent of an accommodating optical structure are machined or moldedas a single structure and a fixed-power lens is affixed to the supportstructure by a bonding means. In many other embodiments, theaccommodating optical structure and a fluid-based haptic structure of anAIOL are comprised of two halves that each incorporate an opticalcomponent of the accommodating optical structure and a portion of thehaptic structure. The two halves are bonded together to form the opticalstructure and the haptic structure. In yet other embodiments, a secondmachining operation can be performed on the bonded structure. Alternatebonding means may include mechanical interfaces such as threading wherethe outer periphery of the lens is threaded and the inner surface of thesupport structure is threaded. In alternate embodiments, the interfacecan be a simple interference fit. In some embodiments, affixingcomprises bonding the materials by treating the one or both of theseparate bonding surfaces with a precursor monomer(s), short chainmultimer(s) or partially prepolymerized base polymer(s), then assemblingthe structure, applying a load across the bonding surfaces, and heatingthe assembly for a period of time. Such a process may facilitatecross-linking between the material comprising both parts. In someinstances, the precursor monomer may be mixed with small particles ofthe polymer. Other bonding agents may additionally include urethanes,silicones, epoxies, and acrylics among others.

In the devices of the present disclosure, the lenses may be compromisedof a water and ion permeable material. In some embodiments, the AIOL canbe allowed to self-fill after implantation, thereby minimizing thedelivery cross-section.

In alternate embodiments, the AIOL is filled after implantation.

Embodiments of the Present Technology

FIG. 1 illustrates a cross section of a radially symmetric AIOL 100comprising a fixed lens 130 and an accommodating structure 140. Theembodiment of the accommodating structure 140 shown in FIG. 1 comprisesa first component 140 a and a second component 140 b that togetherdefine an inner optical structure 142 and an outer fluid reservoir 103.

-   -   100 AIOL    -   101 joint    -   102 posts    -   103 outer fluid reservoir    -   105 fluid chamber    -   107 a first annular stiff region    -   107 b second annular stiff region    -   108 bellows    -   109 a first fold    -   109 b second fold    -   110 first optical component    -   130 fixed lens    -   131 interfacing feature    -   133 relief spaces    -   134 relief    -   140 accommodation structure    -   140 a first component    -   140 b second component    -   142 inner optical structure    -   150 second optical component

Several embodiments of the AIOL 100 may have a base power associatedwith the power of the fixed lens 130 but no base power associated withthe accommodating structure 140 when the accommodating structure 140 isin a relaxed condition (i.e., when no pressure is applied to the outerfluid reservoir 103). The first component 140 a and the second component140 b may be affixed to one another at a seam or joint 101 using, forexample, a bonding agent as described elsewhere herein. The first andsecond components 140 a-b may optionally be affixed at the interfacebetween protrusions 102 (also referred to herein as posts).

The protrusions 102 may be located on the inner surface of one or moreof the first component 140 a and the second component 140 b. Theprotrusions 102 may for example separate the first and second components140 a, 140 b as described elsewhere herein. The joint 101 may extendcircumferentially around the outer perimeter of the first component 140a and the second component 140 b.

The outer fluid reservoir 103 may have a bellows 108, and the inneroptical structure 142 has an inner fluid chamber 105 in fluidcommunications with the outer fluid reservoir 103. The bellows 108 maybe formed from an outer region of the first component 140 a and an outerregion of the second component 140 b. The bellows 108 may comprise oneor more compliant folds 109 (identified individually as 109 a and 109 b)extending continuously circumferentially around an optical axis of oneor more of the first and second components 140 a, 140 b. The one or morefolds 109 a, 109 b of the first and second components 140 a, 140 b,respectively, may for example extend towards each other to define aninner bellows region and an outer bellows region. As a result, the outerfluid reservoir 103 can have one or more folds 109 a-b that defines afold region, which in turn separates an inner bellows region from anouter bellows region. The bellows 108 may comprise a plurality of foldsor pleats.

The inner fluid chamber 105 may be defined between an inner surface ofan inner region of the first component 140 a and an inner surface of aninner region of the second component 140 b. More specifically, the firstcomponent 140 a may have a first optical component 110 at its innerregion, and the second component 140 b may have a second opticalcomponent 150 at its inner region. The fluid chamber 105 shown in FIG. 1can be defined, at least in part, by the first and second opticalcomponents 110 and 150. The bellows 108 may extend continuouslycircumferentially around the first and second optical components 110 and150.

The protrusions 102 are disposed radially outward from the first andsecond optical components 110 and 150 (e.g., between the inner and theouter regions of the first and second components 140 a, 140 b). Thespaces between the protrusions 102 can be fluid channels 149 or conduitsbetween the outer fluid reservoir 103 and the inner fluid chamber 105.The outer fluid reservoir 103 and the inner fluid chamber 105 areaccordingly in fluid communication with each other to provide opticalpower changes in response to shape changes of the lens capsule aspreviously described herein.

The first optical component 110 and/or the second optical component 150may comprise a planar member. The first optical component 110 and/or thesecond optical component 150 may be membranes that have no optical powerin an unbiased state and/or a biased state. The first optical component110 may comprise a deflectable planar member configured to deflect inresponse to fluid transfer between the inner fluid chamber 105 and theouter fluid reservoir 103. For example, when the bellows 108 arecompressed and fluid is forced into the inner fluid chamber 105, thefirst optical component 110 of the first component 140 a may deflectalong the optical path to impart an optical power to the inner opticalstructure 142. Deflection of the first optical component 110 maycomprise changes in one or more of a dimension and shape of the innerfluid chamber 105 such as a change in the distance separating innersurfaces of the first and second optical components 110 and 150. Theoptical power of the inner optical structure 142 (shown in FIG. 10B asregion YY) may, for example, be a factor of the optical power change ofthe AIOL 100. The second optical component 150 may be a planar memberwith a larger cross-section (i.e., thickness) than the first opticalcomponent 110, and thus the second optical component 150 may deform lessthan first optical component 110. Any such deformation of second opticalcomponent 150 may be accommodated by a relief 134 in the fixed lens 130.The relief 135, for example, can be defined by a recess in the fixedlens 130 such that the solid surfaces in the optical field do not toucheven during accommodation.

One or more of the inner regions of the first and second components 140a and 140 b may comprise a shell, such as a non-planar shell (notshown). The first component 140 a may comprise an anterior component,and the second component 140 b may comprise a posterior component.Though shown in the current embodiment as planar members, one or both ofthe optical components 110 and 150 may comprise a plano-convex member oranother standard optical configuration that provides optical power. Inany of the foregoing examples, at least one of the optical components isconfigured to deform as optical fluid is transferred into the opticalportion of the fluid chamber 105. The first component 140 a and thesecond component 140 b may additionally comprise annularly-shaped stiffcoupling regions 107 a and 107 b, respectively, to inhibit radialmovement of the first and second optical components 110 and 150. Thecoupling regions 107 a-b in combination with the fixation between thefirst and second components 104 a-b at the protrusions 102 effectivelyisolate the first and second optical components 110 and 150 from beingdistorted (e.g., deformed) asymmetrically with respect to the opticalaxis of the accommodating structure 140.

The second component 140 b may further comprise an interfacing feature131 which can secure the fixed lens 130 to the second component 140 b asillustrated. The fixed lens 130 may be configured to snap-fit onto thefirst or second component 140 a, 140 b. The fixed lens 130 may besnap-fit onto or otherwise coupled to the first or second component 140a, 140 b in situ within an eye of a patient, such as within a lenscapsule of the eye, for example. The fixed lens 130 may for example havean inner surface facing and adjacent to an outer surface of the first orsecond component 140 a, 140 b to which the fixed lens 130 is coupled.The fixed lens 130 may also have a peripheral relief 133. Theinterfacing feature 131 and the fixed lens 130 may be additionallyconfigured such that interfacing channels exist between the fixed lens130 and the second component 140 b to allow body fluids to freely flowinto any out of relief spaces 134 and 133. The fixed lens 130 may forexample comprise a third component of the AIOL 100. The fixed lens 130may have an optical power.

One or more of the first and second components 140 a, 140 b may comprisea polymeric material as previously described herein. The first andsecond components 140 a, 140 b may be sufficiently flexible to be foldedinto a reduced cross-section delivery configuration for delivery to theeye as previously described herein. The first and second components 140a, 140 b may be bonded to each other as previously described herein. Thefirst and second components 140 a, 140 b may be fabricated as previouslydescribed herein. The third component or fixed lens 130 may besufficiently flexible to be folded into a reduced cross-section deliveryconfiguration for delivery to the eye as well, and as described abovethe fixed lens 130 may be fixedly coupled to the first or secondcomponents 140 a, 140 b in situ.

The AIOL 100 may be filled with a fluid such as any of the fluidspreviously described herein. The fluid in the inner fluid chamber 105may provide optical power to the accommodating structure 140.

The bellows 108 may comprise a continuous baffle structure disposedabout a periphery of the inner fluid chamber 105. The continuousstructure of the bellows 108 may be an annular, elliptical, androtationally symmetric shape as previously elsewhere herein.

The dimensions and geometry of the accommodating lens systems describedherein may be varied. For example, FIG. 2 illustrates an alternate AIOL200.

-   -   200 AIOL    -   240 a first component    -   240 b second component    -   201 joint    -   202 posts    -   203 outer fluid reservoir    -   205 fluid chamber    -   207 a first annular stiff region    -   207 b second annular stiff region    -   208 bellows    -   210 first optical component    -   230 fixed lens    -   231 interfacing feature    -   233 relief space, lens attachment feature    -   234 relief space, deformation chamber    -   250 second optical component

The AIOL 200 comprises structures similar to AIOL 100, and the last twodigits of the reference numerals identify similar structures. The AIOL200 can have a second component 240 b with a second optical component250 that is thinner than the second optical component 150. The secondoptical component 250 may therefore deform in a fashion which increasesthe accommodative optical power of the AIOL 200 compared to the AIOL100. The additional deformation of the thin second optical component 250may occur within a deformation relief 234 in the second opticalcomponent 250 instead of the fixed lens 130 in the AIOL 100. In anotherembodiment (not shown), the AIOL 200 can have the deformation relief 234in the second optical component 150 and the deformation relief 134 ofthe fixed lens 130 of the AIOL 100 in the same device. The AIOL 200 canalso include an outer fluid reservoir 203 comprising two folds in onlythe first component 140 a of the AIOL 200. For example, the outer regionof the first component 240 a may define a bellows 208 having two folds209, while the outer region of the second component 240 b has none(e.g., a flat portion).

In other examples, the geometry of the fluid chamber or the bellows orother fluid reservoir structure may be varied. For example, FIG. 3illustrates an AIOL 300, which is similar in structure to the AIOL 200,in which the last two digits of the reference numerals identify similarstructures. The AIOL 300 comprises an outer fluid reservoir 303 thatextends continuous and circumferentially around an inner fluid chamber305 and stiff annular regions 307 a-b. The outer fluid reservoir 303 hasa rectilinear cross-sectional shape. The AIOL 300 accordingly has afold-less bellows 308 that drives fluid into or receives fluid from theinner fluid chamber 305.

-   -   300 AIOL    -   340 a first component    -   340 b second component    -   301 joint    -   302 posts    -   303 outer fluid reservoir    -   305 fluid chamber    -   307 a annular stiff region—a    -   307 b annular stiff region—b    -   308 bellows    -   310 first optical component    -   330 fixed lens    -   331 interfacing feature    -   333 relief space, lens attachment feature    -   334 relief space, deformation chamber    -   350 second optical component

The various peripheral fluid-filled bellows 108, 208, 308 of AIOLs 100,200, and 300, respectively, provide control of the stiffness of theouter fluid reservoir. This allows the AIOLs to provide the desiredaccommodation based on the forces applied by the eye on the structureand the resulting accommodation.

FIGS. 4A, 4B, and 4C illustrate an AIOL 400 similar to embodiments ofthe AIOLs 100, 200, and 300 above, in which the last two digits of thereference numerals identify similar structures.

-   -   400 AIOL    -   440 a first component    -   440 b second component element    -   440 c outer ring element    -   401 joint    -   402 posts    -   403 outer fluid reservoir    -   405 fluid chamber    -   407 a annular stiff region    -   407 b annular stiff region    -   408 bellows    -   410 first optical component    -   430 fixed lens    -   431 interfacing feature    -   433 relief space    -   434 relief space    -   435 latching mechanism    -   450 second optical

The AIOL 400 may have four primary parts including: a first component440 a; a second component 440 b; a fixed lens 430 defining a thirdcomponent; and an outer ring element 440 c defining a fourth element(e.g., a thin-walled ring). The outer ring element 440 c may be affixedto the first component 440 a and the second component 440 b at seams orjoints 401 to couple the first and second components 440 a, 440 b to oneanother at their peripheries. The outer ring element 440 c, the firstcomponent 440 a, and the second component 440 b may together define theouter fluid reservoir 403, which is in fluid communication with a fluidchamber 405 of an accommodating structure 440. The outer ring element440 c may be fabricated of a material with different material propertiesthan the rest of the components of the structure. In some embodiments,the outer ring element 440 c may be fabricated with a version of thepolymer used to fabricate the first component 440 a and second component440 b with a reduced modulus of elasticity. The outer ring element 440 cmay therefore be more easily fabricated and it may have a thinnercross-section than might otherwise be possible. Alternatively, or incombination, the outer ring element 440 c can be spin cast orcentripetally cast, thus allowing for structures even thinner than mightbe obtainable by machining.

The AIOL 400 may have a fixed lens 430 comprising a convex concaveconfiguration. The fixed lens 430 may be attached to the secondcomponent 440 b by a latching mechanism 435 that interlocks with aninterface feature 431. The AIOL 400 may have a relief 434 created byoffsetting the latching mechanism 435 and the convex surface of thefixed lens 430.

FIG. 5 illustrates an AIOL 500 which is a variation of the AIOL 400, andthe last two digits of the reference numerals identify similarstructures.

-   -   500 AIOL    -   501 joint    -   540 accommodating structure    -   540 a first component    -   540 b second component    -   540 c outer ring    -   570 slot

The AIOL 500 has first interface zones between the first component 540 aand the outer ring 540 c, and second interface zones between the secondcomponent 540 b (not visible) and the outer ring 540 c. The first andsecond interface zones may have slots 570 to increase the flexibility ofthe outer peripheral portion of the AIOL 500. The slots 570 may befabricated in the structural components comprising AIOL 500 before orafter the components have been assembled. Slots 570, when added afterthe structure has been assembled, may be created by one or more ofmechanical cutting, laser cutting, and any other suitable means. Theslots 570 may be created such that they extend partially down a seam sothat a portion of the seam remains uncut and the seal between componentsof AIOL remains intact.

FIGS. 6A, 6B and 6C illustrate aspects of an AIOL 600, which is anadditional embodiment of an AIOL similar to embodiments of the AIOLs100, 200, 300, 400 and 500.

-   -   600 AIOL    -   640 a first component    -   640 b second component    -   601 joint    -   603 outer fluid reservoir    -   603 a inner continuous bellows    -   603 b outer continuous bellows    -   607 annular stiff region    -   608 bellows    -   610 first optical component or planar member    -   612 fluid accommodating Lens    -   620 through hole    -   630 fixed lens    -   631 interfacing feature or fixed lens receiver    -   640 accommodating structure    -   641 aqueous chamber    -   649 fluid channel    -   650 second optical component or optic membrane    -   651 square edge    -   653 side-B AIOL    -   654 fixed lens receiver    -   655 bonding pin    -   656 bonding pin receiver    -   657 stand off

The AIOL 600 comprises three primary structures (FIG. 6B) including (a)a fixed lens 630, (b) a first component 640 a, and (c) a secondcomponent 640 b. The first and second components 640 a and 640 b arebonded together at a seam 601 to define an outer fluid reservoir 603 asshown in the cross-sectional view FIG. 6A.

The first component 640 a has a fixed lens receiver 631 (FIG. 6C) and anaqueous chamber 641. The fixed lens 630 is attached to the firstcomponent 640 a at a fixed lens receiver 631, and the fixed lens 630 canhave at least one through hole 620 that allows aqueous fluid in the lenscapsule to flow into and out of the aqueous chamber 641. The firstcomponent 640 a can be the anterior portion of the AIOL 600, and thelens receiver 631 can be configured to enable the correct fixed lenspower for the patient to be identified and provided at the time of theprocedure after an accommodating portion 640 (i.e., the first and secondcomponents 640 a and 640 b) has been placed in the native eye capsule.The fixed lens 630 can be selected after the accommodating portion 640has been implanted in the native eye capsule so that the optical powerof the fixed lens 630 compensates for any optical power exhibited by theaccommodating structure 640 when in the relaxed capsule. This aspect ofAIOL 600, and several other AIOLs described herein, is possible becausethe first components 640 a is the anterior portion of the AIOL 600.

The fixed lens 630 can also be selected to accommodate the refractiverequirements of the patient after the accommodating structure 640 hasbeen implanted. For example, the accommodating structure 640 can changethe refractive requirements of the patient, and thus selecting the fixedlens 630 after implanting the accommodating structure 640 allowspractitioners to meet the refractive requirements of the patients usingthe fixed lens 630.

Another feature of the AIOL 600 is the manner in which first component640 a is attached to second component 640 b (FIG. 6C). The firstcomponent 640 a comprises bonding pins 655 and the second component 640b comprises bonding pin receivers 656 configured to receive (e.g., mate)with the bonding pins 655. The first component 640 a further comprisesstandoffs 657 (FIG. 6B) which form a fluid chamber 612 (FIG. 6A) betweena first optical component 610 and a second optical component 650 whenthe first and second component 640 a and 640 b are attached together.When an optical fluid is in the fluid chamber 612, the optical fluiddefines an accommodating lens bounded between the first opticalcomponent 610 and the second optical component 650. The fluid can flowinto and out of the fluid chamber 612 through discrete fluid channels649 defined by the spaces between standoffs 657 and bonding pins 655when the first and second components 640 a and 640 b are assembled.

An additional feature of the AIOL 600 is the distance between the fixedlens 630 and the first optical component 610 that defines the depth ofthe aqueous chamber 641 (FIG. 6A). The fixed lens 630 is spaced apartfrom the first optical component 610 such that the first opticalcomponent 610 can deflect anteriorly (shown by broken lines) by asufficient amount to provide the desired accommodation. The distancebetween the first optical component 610 in an unbiased planar state(shown in solid lines) and the fixed lens 630 can be 1 μm to 4000 μm, orin some applications 4 μm to 800 μm.

The first and second optical components 610 and 650 may be planarmembers, such as optical membranes, and they may be situated upon matingfirst and second components 640 a and 640 b, as shown in FIG. 6C. TheAIOL 600 can further include a square-shaped annular region 651 thatprovides a barrier to cell migration from the periphery of the patient'scapsule to the optical field of view of AIOL 600. As shown in FIG. 6A,the square-shaped annular region 651 can define a sharp corner at theposterior most region of the lens to inhibit cell migration that couldcause post-surgery opacification of the optical system.

FIGS. 7A and 7B illustrate an embodiment of a second component 740 bthat can be used in the AIOL 600 illustrated in FIGS. 6A-6C. Morespecifically, the second component 640 b of the AIOL 600 may be replacedwith the second component 740 b as illustrated in FIGS. 7A and 7B.

-   -   703 outer fluid reservoir    -   740 b second component    -   750 second optical component    -   756 receivers    -   757 standoff    -   760 thickened feature

An additional feature of the AIOL 600 is the distance between the fixedlens 630 and the first optical component 610 that defines the depth ofthe aqueous chamber 641 (FIG. 6a ). The fixed lens 630 is spaced apartfrom the first optical component 610 such that the first opticalcomponent 610 can deflect anteriorly (shown in broken lines) by asufficient amount to provide the desired accommodation. The distancebetween the first optical component 610 in an unbiased planar state(shown in solid lines) and the fixed lens 630 can be 0.2 mm-2.0 mm, orin some applications 0.4 mm-0.8 mm.

FIGS. 7A and 7B illustrate a top view and sectional side view,respectively, of the second component 740 b. The second component 740 bcomprises a thickened feature 760 that defines a portion of the outerfluid reservoir 703 b. The thickened feature 760 provides for a longermaterial path for use in accessing the interior of the completedassembly via a needle or tubular member to inject a fluid into theinterior of the assembly. The longer path of the needle through the bulkmaterial of thickened feature 760 provides for more surface area to sealthe path when the needle is removed. This possibly eliminates the needfor additional sealing measures after removing the needle. Asillustrated, the second component 740 b also comprises an alternatebonding pin receiving feature 756 which is comprised of a recess asopposed to a hole as embodied in the bonding pin receiver 656 of AIOL600.

FIG. 8 illustrates an embodiment of an AIOL 800 that is similar to theembodiments of the AIOLs and components shown in FIG. 6 and FIG. 7. InFIG. 8 various structures are identified by various reference numeralsand the last two digits of the reference numerals identify similarstructures to those described in embodiments of the AIOIs 600 and 700.

-   -   800 AIOL system    -   801 seam    -   803 outer fluid reservoir    -   810 first optical component    -   812 fluid chamber, fluid accommodating lens    -   830 fixed lens    -   831 fixed lens receiver    -   840 accommodating structure    -   840 a first component    -   840 b second component    -   850 second optical component    -   851 multiple annular regions    -   855 standoffs    -   856 continuous receiver ring    -   860 thickened features

The AIOL 800 includes multiple square-shaped annular regions 851. Forexample, the AIOL 800 can have 4 circular, square-edged regions 851incorporated in the posterior (P) and anterior (A) regions of the outerfluid reservoir 803. The square-shaped regions 855 can further inhibitcell migration associated with posterior capsule opacification. Theembodiment of the AIOL 800 shown in FIG. 8 additionally incorporates twothickened features 860 in the second component 840 b to allow for fluidinflow and fluid outflow during the filling procedure. These thickenedfeatures 860 are shown in cross section and subtend circumferentialangles similar to that of the thickened feature 760 (FIG. 7). In anothervariation on the embodiments of the AIOLs 600 and 700, the firstcomponent 840 a includes standoffs 855 and the second component 840 bincludes a continuous receiver ring 856 that interfaces with thestandoffs 855.

FIGS. 9A-C and 10A-C illustrate embodiments of AIOLs 900 and 1000,respectively, similar to the embodiments AIOLs 600, 700, 800, in whichadditional features have been incorporated to enhance performance.Various structures are identified by reference numerals in FIGS. 9A-Cand 10A-C, and the last two digits of such reference numbers identifysimilar structures to those described above with reference to FIGS.6A-8.

-   -   900 AIOL    -   903 outer fluid reservoir    -   920 passages    -   930 fixed lens    -   940 accommodating structure    -   940 a first component    -   940 b second component    -   955 bonding pin    -   956 bonding pin receiver    -   960 thickened features    -   966 capsular rotation constraint    -   967 receiver    -   968 key    -   969 toric indexing mark    -   970 toric indexing feature    -   1000 AIOL    -   1003 outer fluid reservoir    -   1030 toric fixed lens    -   1040 accommodating structure    -   1040 a first component    -   1040 b second component    -   1055 standoff    -   1056 receiver ring    -   1060 thickened feature    -   1066 capsular rotation constraint    -   1067 receiver    -   1068 key    -   1070 toric indexing feature

The embodiments of the AIOLs 900 and 1000 comprise capsular rotationconstraint features 966 and 1066, respectively, which enhanceperformance when the AIOLs 900 and 1000 have a toric lens. The toriclens may be in either the accommodating portion or the fixed portion ofthe AIOL. The capsular rotation constraint features 966 and 1066 inhibitrelative rotation between the optical components themselves and/or withrespect to the capsule into which they have been implanted. Asillustrated here, the fixed lenses 930 and 1030 are toric lenses. Thecapsular rotation constraints 966 (FIGS. 9A and 9C) and 1066 (FIGS. 10Aand 10C) are located on the outer periphery of the device to engage thelens capsule of the eye and inhibit rotation of the AIOL system withinthe native lens capsule. The capsular rotation constraints 966 and 1066can be thickened portions of the first and/or second component 940 a/1040 a or 940 b/ 1040 b on the outer periphery of the AIOLs 900 and1000, respectively. Alternate embodiments for the capsular rotationconstraints can include any feature that engages the native capsule moresecurely than other surfaces on the periphery of the AIOL to inhibitrotation of the AIOL with respect to the native eye capsule.Alternatively, the AIOLs 900 or 1000 can have only single capsularrotation constraint 966 or 1066 or more than two capsular rotationconstraints 966 or 1066.

In addition to the capsular rotation constraints 966 and 1066, the AIOLs900 and 1000 can also include features that maintain the rotationalorientation of the fixed lens 930/1030 relative to the accommodatingstructures 940/1040 of the AIOLs 900/1000. The capsular rotationconstraints 966/1066 can define toric indexing features of the AIOLs 900and 1000 that reference the rotational orientation of the fixed lens930/1030 relative to the accommodating structures 940/1040. The fixedlens 930 of the AIOL 900 can also have a plurality of passages 920defined by cutouts or holes along the perimeter of the fixed lens 930,and one of the passages 920 defines a receiver 967 at a location toguide the proper orientation of the fixed lens 930 with respect to thefirst component 940 a. The first component 940 a comprises a key 968 ata corresponding radial location to align the toric fixed lens 930. Thereceiver 967 and the key 968 together define a toric indexing feature970. The fixed lens 930 can further include a toric indexing mark 969on, or in, the fixed lens 930 that identifies which passage 920 definesthe receiver 967 that is to be aligned with the key 968. Alternatively,instead of having the toric indexing mark 969, the key/receiverassociated with the correct alignment can have a different shape (e.g.,triangular) than the other passages 920 in the lens (e.g., curved). FIG.10B illustrates an alternate embodiment in which the receiver 1067 is acutout or recess in the inner perimeter of the first component 1040 a,and the toric fixed lens 1030 comprises a key 1068 configured to matewith the receiver 1067.

The thickened regions of the capsular rotation constraints 966 and 1066of the AIOLs 900 and 1000 further provide a more robust leading edge foruse when delivering the AIOLs 900 and 1000 through a narrow boreconstriction or tube of an AIOL delivery device as described withrespect to FIG. 11. One of the thickened rotation constraints 966 and1066 can be positioned to be a leading edge of the AIOL systems 900 and1000 and the other a trailing edge as they are passed through the narrowbore or tube of a delivery device. By having the thickened rotationconstraints 966, 1066 define a leading edge during delivery, the leadingportion of the AIOLs 900, 1000 can sustain larger pressures as theleading section of the AIOLs 900, 1000 compresses during the deliveryprocess when the most distal portion has entered the constricted zone ofthe delivery tool. More specifically, fluid trapped in the AIOLs 900 and1000 can rupture the material as the leading edge is compressed. Thus,increasing the thickness of the material at the leading edge enables theAIOLs 900 and 1000 to withstand the compression forces during delivery.In some embodiments, the AIOLs 900 and 1000 have only a single rotationconstraint 966/1066.

FIG. 11 schematically illustrates how one of the thickened rotationalconstraints 966 of the AIOL system 900 operates in a distal tip of adelivery device 1100 during delivery. Various structures are identifiedby reference numerals in FIG. 11, and the last two digits of suchreference numbers identify similar structures to those described abovewith reference to FIGS. 6A-10C.

-   -   1100 AIOL delivery device    -   900 AIOL    -   966 capsular rotation constraint    -   1175 injector tip    -   1176 insertion funnel    -   1177 plunger    -   1178 flexible distal end

The AIOL 900 is shown properly oriented relative to the capsularrotation constraints 966 and entering the injector tip 1175 fordelivery. The AIOL 900 conforms to the delivery tool constrictions whilebeing pushed through an insertion funnel 1176 by a flexible distal end1178 of a plunger 1177. It will be appreciated that the internalpressure of the fluid in the AIOL 900 increases as it is compressed inthe insertion funnel 1176, and the thickened rotation constraint 966 atthe leading edge provides more material to withstand the increase inpressure and protect the front end from rupturing during delivery.

FIGS. 12A-12C illustrate an alternative AIOL 1200 comprising at leastone mid-bellows attachment feature 1271 (shown in the cross-sectionalviews of in FIGS. 12B-12C). Various structures are identified byreference numerals in FIG. 12, and the last two digits of such referencenumbers identify similar structures to those described above withreference to FIGS. 6A-10C.

-   -   1200 AIOL    -   1201 seam    -   1203 outer fluid reservoir    -   1205 fluid chamber    -   1210 first optical component    -   1212 fluid accommodating lens    -   1230 fixed lens    -   1240 a first component    -   1240 b second component    -   1250 second optical component    -   1251 square-shaped annular edge    -   1255 standoff    -   1256 receiver ring    -   1260 thickened feature    -   1266 capsular rotation constraint    -   1271 mid-bellows attachment feature    -   1271 a first mating element    -   1271 b second mating element    -   1272 mating region

The AIOL 1200 is similar to the embodiment of the AIOL 1000 describedherein. For example, the illustrated embodiment of the AIOL 1200comprises first and second components 1240 a and 1240 b, respectively,that are bonded together at a seam 1201 to define an outer fluidreservoir 1203. The AIOL 1200 further comprises a fixed lens 1230, afirst optical component 1210, a second optical component 1250, and afluid chamber 1205 between the first and second optical components 1210and 1250. At least one of the first and second optical components 1210and 1250 is deformable (e.g., able to flex anteriorly and/orposteriorly), and in several embodiments the first optical component1210 is more deformable than the second optical component 1250. Forexample, the first optical component 1210 can be a thin flexible member,while the second optical component 1250 is at least substantially rigid(e.g., does not flex in a manner that changes the optical power). Thefirst optical component 1210 and/or the second optical component 1250 incombination with an optical fluid in the fluid chamber 1205 define afluid accommodating lens 1212. The AIOL 1200 also includes (a) thickenedfeatures 1260 that facilitate fluid delivery during the fillingprocedure as described herein with respect to features 760, and (b) asquare-shaped annular edge 1251 that provides a barrier to inhibit cellmigration from the periphery of the patient's capsule to portions of theAIOL 1200 within the optical path.

The AIOL 1200 includes mid-bellows attachment features 1271 that eachcomprise first and second mating elements 1271 a and 1271 b integratedinto the first and second components 1240 a and 1240 b, respectively.The first and second mating elements 1271 a and 1271 b are joinedtogether at a mating region 1272. The mid-bellows attachment features1271 may be distributed circumferentially around the midsection of theouter fluid reservoir 1203 at a plurality of discrete locations that arespaced apart from each other. For example, in the embodiment of the AIOL1200 shown in FIGS. 12A-12C, the mid-bellows attachment features 1271are evenly distributed at eight locations (not all are shown) spacedapart around the midsection of the outer fluid reservoir 1203, howeverthe mid-bellows attachment features 1271 are not limited to a specificquantity.

The mid-bellows attachment features 1271 provide a more efficienttransfer of fluid from the outer fluid reservoir 1203 to the fluidchamber 1205 of the AIOL 1200. More specifically, without themid-bellows attachment features 1271, the apexes of the periphery of thefirst and second components 1204 a and 1204 b can separate from eachother as pressure increases in the outer fluid reservoir 1203 duringaccommodation. The mid-bellows attachment features 1271 may limit suchundesirable or excessive expansion in the midsection of the outer fluidreservoir 1203 during accommodation by inhibiting separation of theapexes of the periphery of the first and second components 1204 a and1204 b. Conversely, the mid-bellows attachment features 1271 can supportthe midsection of the outer fluid reservoir 1203 to inhibit it fromcollapsing and trapping fluid in the outer fluid reservoir 1203. Themid-bellows attachment features 1271 accordingly stabilize the volume ofthe midsection of the outer fluid reservoir 1203 as pressure increasesin the outer fluid reservoir 1203 such that more of the fluid flows fromthe outer fluid reservoir 1203 and into the fluid chamber 1205 thanwithout the mid-bellows attachment features 1271. This provides for amore efficient transfer of the accommodating fluid from the outer fluidreservoir 1203 to the fluid chamber 1205 of the fluid accommodating lens1212. FIG. 12B illustrates a section through the AIOL 1200 which passesthrough two of the mid-bellows attachment features 1271, and FIG. 12Cillustrates a section of the AIOL 1200 that passes through two spacesbetween mid-bellows attachment features 1271 that allow fluid to passfrom the outer fluid reservoir 1203 to the fluid chamber 1205.

The mid-bellows attachment features 1271 are not limited to use in theembodiments of the AIOL 1200 described above with reference to FIGS.12A-12C, but rather may be incorporated into any appropriate embodimentof an AIOL with an outer fluid reservoir and a fluid chamber disclosedherein.

Additional embodiments of AIOLs 1300, 1400, 1500, and 1600, areillustrated in FIGS. 13A through 16B, and each of the AIOLs 1300, 1400,1500 and 1600 comprise flow features which facilitate the flow ofmaterials from the posterior side of the AIOL to the anterior side ofthe AIOL. These flow features may reduce or eliminate the trapping orstagnation of materials between the capsule and the posterior aspect ofthe AIOL. In particular, these flow features may enhance the rate andease with which Ophthalmic Viscosurgical Devices (OVDs) used during theimplantation of AIOLs can be removed from the natural lens capsule.

The AIOL 1300 illustrated in FIGS. 13A through 13J comprises twodifferent flow features: a first flow feature is defined by outerflow-throughs 1381 and a second flow feature is defined by innerflow-throughs 1382.

-   -   1300 AIOL    -   1301 seam    -   1302 protrusions    -   1303 outer fluid reservoir    -   1303 a first bellows structure    -   1303 b second bellows structure    -   1310 first optical component    -   1305 fluid chamber    -   1330 fixed lens    -   1331 fixed lens receiver    -   1340 a first component    -   1340 b second component    -   1349 fluid channel    -   1351 square-shaped annular edge    -   1355 standoff    -   1356 bonding pin receiver    -   1360 thickened features    -   1371 mid-bellows attachment feature    -   1371 a first mating element    -   1371 b second mating element    -   1373 mid-bellows channels    -   1381 outer flow-through, recess    -   1382 inner flow-through, hole

The outer flow-through feature 1381 can be detents, such as a recess, atregions around the perimeter of the device. The inner flow-throughfeature 1382 can be a mid-bellows through hole that passes throughportions of two of the mid-bellows attachment features 1371 betweenmid-bellows channels. As illustrated, the inner flow-throughs 1382comprise circular holes, but in alternate embodiments the innerflow-throughs 1382 may be slots. Although only two inner flow-throughs1382 are illustrated, the AIOL 1300 may comprise more than two. Ingeneral, there can be as many inner flow-throughs 1382 as there aremid-bellows attachment features 1371. In some embodiments, the innerflow-throughs 1382 may be added after fabricating the AIOL 1300 by lasercutting or drilling, or in other embodiments the inner flow-throughs1382 can be formed in the parts prior to assembly (e.g., molded or cutinto the parts before assembly). Although two outer flow-throughs 1381are illustrated, other embodiments of the AIOL 1300 may comprise feweror more than two flow-throughs. The outer flow-throughs 1381additionally provide rotational constraint as described above withregard to the embodiment of the AIOL 1000.

FIGS. 14 and 15 present AIOL embodiments 1400 and 1500, respectively,with the following feature references:

-   -   1400 AIOL    -   1403 outer fluid reservoir    -   1420 passages    -   1430 fixed lens    -   1432 skirt    -   1436 optical portion    -   1440 a first component    -   1473 mid-bellows channels    -   1500 AIOL    -   1520 passages    -   1530 fixed lens    -   1531 engagement feature    -   1532 skirt    -   1536 optical portion    -   1540 a first component

The embodiments of AIOLs 1400 and 1500 have fixed lens assemblies 1430and 1530, respectively, that (a) allow fluid to flow through the fixedlens assemblies, (b) center the fixed lens assemblies 1430 and 1530 inthe device, and (c) enhance the structural stiffness at the inner areaof the outer fluid reservoir 1403. The fixed lens assembly 1430illustrated in FIG. 14C includes an optical portion 1436, a skirt 1432extending from the optical portion 1436, and passages 1420. The opticalportion 1436 has a fixed power as explained above, and the passages 1420are holes, slots, orifices, etc., that pass through the skirt 1432 andextend into a perimeter region of the optical portion 1436. The fixedlens assembly 1530 shown in FIG. 15A can similarly include an opticalportion 1536, a skirt 1532 extending from the optical portion 1536, andpassages 1520 through the skirt and into a perimeter region of theoptical portion 1536. In these embodiments, the passages 1420 and 1520provide for fluid transfer as previously described with respect to,e.g., through hole 620 described herein with reference to AIOL 600. Thepassages 1420 and 1520 also reduce the volume of the fixed lens allowingthem to be delivered through a smaller delivery tool.

Referring to FIGS. 14D and 14E, the skirt 1432 of the fixed lensassembly 1430 diverges radially outward from the anterior side A to theposterior side P of the AIOL 1400 (i.e., in the posterior direction theskirt 1432 is inclined outwardly to slope away from the optical axis ofthe optical portion 1436). This allows the inner wall of the firstcomponent 1440 a to retain the fixed lens assembly 1430. The AIOL 1400also can include a mid-bellows channel 1473 (illustrated in FIGS. 14Dand 14E) that allows fluid to flow from the outer portion to an innerportion of the outer fluid reservoir 1403 (FIG. 14E).

Referring to FIGS. 15C and 15D, the skirt 1532 of the fixed lens 1530converges radially inward from the anterior side A to the posterior sideP of the AIOL 1500 (i.e., in the posterior direction the skirt 1532 isinclined inwardly to slope toward the optical axis of the opticalportion). The AIOL 1500 further includes a lip 1531 around the anteriorregion of the fixed lens assembly 1530 to retain the fixed lens assembly1530 in the desired position.

During implantation, when the folded fixed lens is delivered into theeye after the accommodating portion has been delivered, the skirtcenters the fixed lens as it unfolds and securely holds the fixed lenswithin the accommodating portion when fully expanded. More specifically,either skirt 1432 or 1532 will automatically position the opticalportion 1436 and 1536, respectively, at the desired position relative tothe optical axes of the devices as the skirts 1432 and 1532 engage thefirst components 1440 a and 1540 a. Additionally, the height/depth ofthe skirts 1432 and 1532 will also space the optical portion 1436 and1536, respectively, at a desired distance from the first opticalcomponents 1410 and 1510 of the accommodating lenses. This will allow apractitioner to press the fixed lens assemblies 1430 and 1530 into placewithout risking pushing the optical portions 1436 and 1536 too far intothe first structural elements 1440 a and 1540 a.

FIGS. 16A and 16B illustrate an AIOL 1600 similar to the embodiment ofthe AIOL 1400. The AIOL 1600 has a first component 1640 a comprising atleast one thickened portion 1668 on the inner wall that is shaped tointerface with one or more of the passages 1620 in the fixed lensassembly 1630.

-   -   1600 AIOL system    -   1601 seam    -   1603 outer fluid reservoir    -   1603 a first bellows structure    -   1603 b second bellows structure    -   1610 first optical component    -   1620 passages    -   1630 fixed lens    -   1632 skirt    -   1636 optical portion    -   1640 accommodating structure    -   1640 a first component    -   1640 b second component    -   1641 chamber    -   1650 second optical component    -   1651 multiple annular region    -   1655 standoff    -   1656 receiver ring    -   1668 thickened portions    -   1671 mid-bellows attachment feature    -   1673 mid-bellows channel

The interface between the thickened portions 1668 and the respectivepassage 1620 securely fixes the fixed lens 1630 in place and providesfor proper alignment of the fixed lens 1630 when the fixed lens 1630comprises a toric configuration. In such an embodiment, the fixed lens1630 may comprise any of the orientation markings described elsewhereherein.

FIGS. 17A-17G have the following features.

-   -   1700 AIOL    -   1701 seam    -   1703 outer fluid reservoir    -   1703 a first bellows structure    -   1703 b second bellows structure    -   1705 fluid chamber    -   1708 bellows    -   1710 first optical component    -   1712 space    -   1720 passages    -   1730 fixed lens    -   1731 engagement feature    -   1732 skirt    -   1736 optical portion    -   1740 accommodating structure    -   1740 a first component    -   1740 b second component    -   1741 chamber    -   1749 fluid channel    -   1750 second optical component    -   1751 square-shaped annular edge    -   1755 standoff    -   1756 receiver ring    -   1760 fluid fill thickened section    -   1768 lens engagement thickened region    -   1771 mid-bellows attachment feature    -   1773 mid-bellows channel    -   1781 outer flow-through features

FIGS. 17A and 17B illustrate an embodiment of an AIOL 1700 that includesenhanced flow-through features 1781 to facilitate the flow of materialsfrom the posterior side of the AIOL 1700 to the anterior side of theAIOL 1700. In particular, the flow-through features 1781 may enhance therate and ease with which Ophthalmic Viscosurgical Devices (OVDs) usedduring the implantation of AIOLs can be removed from the natural lenscapsule. The embodiment of the AIOL 1700 illustrated in FIGS. 17A-17Ecomprises three outer flow-through features 1781. The outer flow-throughfeatures 1781 can be detents, such as a recess, distributedcircumferentially along the perimeter of the outer fluid reservoir 1703.In the illustrated embodiment, the flow-through features 1781 are formedin regions of the first and second components 1740 a and 1740 b.Although three outer flow-through features 1781 are illustrated, otherembodiments may comprise less or more than illustrated. The outerflow-through features may additionally provide rotational constraint asdescribed herein with regard to the AIOL of embodiment 1000.

The embodiment of the AIOL 1700 additionally comprises an alternatedesign for a fixed lens assembly 1730. The fixed lens assembly 1730illustrated in FIG. 17C includes an optical portion 1736, a skirt 1732extending from the optical portion 1736, and passages 1720. The opticalportion 1736 has a fixed power which may comprise an asymmetricallypowered lens or other lens as explained herein, and the passages 1720are holes, slots, orifices, etc., that pass through the skirt 1732 andextend into a perimeter region but not the optical portion 1736.

Referring to FIG. 17C, the fixed lens assembly 1730 has an engagementfeature 1731, such as an annular groove, that extends around the skirt1732, and the first component 1740 a of the accommodating structure 1740has a thickened region 1768, such as an annular protrusion (e.g., aledge) that extends radially inwardly. The fixed lens assembly 1730 canbe attached to the accommodating structure 1740 by engaging thecontinuous thickened region 1768 of the first component 1740 a with theengagement feature 1731 of the fixed lens 1730. In other embodiments(not shown), the thickened region 1768 and the engagement feature 1731may be discontinuous features (e.g., segmented or other recesses orprotrusions that extend around less than the full circumference of thefixed lens assembly 1730 and the accommodating structure 1740). Suchdiscontinuous thickened region 1768 and engagement feature 1731 aredesirable to maintain a particular radial alignment between the fixedlens assembly 1730 and the accommodating structure 1740, such as whenthe fixed lens 1730 comprises a toric lens or other asymmetrical lens.Alternatively, the groove may be in the fixed lens 1730 and theprotrusion on the accommodating structure 1740.

The AIOL 1700 has a fluid accommodating lens 1712 defined by a fluidchamber 1705 (FIGS. 17D and 17E) bounded between a first opticalcomponent 1710 and a second optical component 1750. The fluid chamber1705 is in fluid communication with the outer reservoir 1703 viadiscrete fluid channels 1749 between standoffs 1756 when the first andsecond components 1740 a and 1740 b are assembled. The first and secondoptical components 1710 and 1750 may be planar members (e.g., opticalmembranes) of the first and second components 1740 a and 1740 b,respectively, as shown in FIG. 17E. The first and second opticalcomponents 1710 and 1750, for example, can be integrally formed asoptical membranes with the other portions of the first and secondcomponents 1740 a and 1740 b. In alternate embodiments, either or bothof the membranes of the first and second optical components 1710 and1750 may be a lens (i.e., have an optical power).

The AIOL 1700 can further include a square-shaped annular region 1751that inhibits cell migration from the periphery of the patient's capsuleto the optical part of AIOL 1700 (shown in FIG. 17D at the posteriormost region of the lens). Such cell migration could cause post-surgeryopacification of the optical system.

The peripheral portions of the first component 1740 a and the secondcomponent 1740 b define the outer fluid reservoir 1703, and the innerportions of the first and second components 1740 a and 1740 b define theaccommodating structural element 1740. The first and second components1740 a and 1740 b can be bonded together at a seam 1701 by means asdescribed elsewhere herein. The first and second components 1740 a and1740 b can also be bonded at other areas, such as at the standoffs 1755.The standoffs 1755 are separated by spaces that define fluid channels1749 between the outer fluid reservoir 1703 and the inner fluid chamber1705. The outer fluid reservoir 1703 can be a bellows 1708 having anouter bellows region 1703 a and an inner bellows region 1703 b.

The outer fluid reservoir 1703 has less volume that the outer fluidreservoirs of other AIOLs described herein, and in particular the volumeof the inner bellows region 1703 b is less than the outer bellows region1703 a. By reducing the volume of the inner bellows region 1703 b,additional space surrounding the optical region of the AIOL allows theoptical aperture of the fixed lens 1730 to be larger compared toembodiments with larger inner bellows regions. Additionally, thepassages 1720 of the fixed lens 1730, which allow aqueous fluid tofreely flow in and out of the chamber 1741, are configured to passthrough only the outer skirt 1732 and not the top optical portion 1736.This is expected to reduce unwanted scattered light from internalreflections which may pass through the optical system and reach theretina.

The first component 1740 a may also comprise one or more thickenedregions 1760 for use as described above with respect to, for instance,the thickened region 1760 of the AIOL 700 for use in filling the AIOLwith an optical fluid. The thickened region 1760 allows for a longerpath for a needle used to fill the accommodating structure with opticalfluid while a second needle in a different region is used to remove thegases the fluid is replacing. As illustrated, the fluid fill thickenedregion 1760 is located adjacent one or more of the outer fluidflow-throughs 1781.

Referring to FIG. 17E, the outer fluid reservoir 1703 of the AIOL 1700can comprise (a) a first bellows structure 1703 a with an anteriorportion 1704 a and a posterior portion 1704 b, (b) a second bellowsstructure 1703 b radially inward of the first bellows structure 1704 a,and (c) a mid-bellows channel structure 1773 defining a horizontalpassageway between the first and second bellows structures 1703 a and1703 b. During operation as the capsule contracts, a mid-portion of thefirst bellows structure 1703 a is constrained by the mid-bellows channel1773 while the anterior and posterior portions 1704 a and 1704 b of thefirst bellows structure 1703 a move radially inward with respect to themid-bellows channel 1773. The anterior and posterior portions 1704 a and1704 b of the first bellows structure 1703 a will accordingly flexradially inward to a greater extent than some other outer reservoirstructures described above (e.g., outer fluid reservoir 103 shown inFIG. 1) in response to the same amount of movement of the nativecapsule. This causes more fluid to flow from the outer fluid reservoir1703 to the inner fluid chamber 1705 and thereby provides moreaccommodation because anterior-posterior collapse of the outer fluidreservoir 1703 is less efficient than radial compression of the outerfluid reservoir 1703.

FIGS. 17F and 17G show channels 1744 that extend around the perimeter ofthe first and second components 1740 a and 1740 b to narrow the spacefor the thickened portions 1760 compared to, e.g., the thickenedportions 1360 shown in FIGS. 13I and 13J. The narrower thickenedportions 1760 are more flexible than the thickened portions 1360, whichenhances the amount of fluid transport between the outer fluid reservoir1703 and the inner fluid chamber 1705 in response to the same amount ofmovement of the native capsule.

Although not shown, in some embodiments, a portion of the outerstructure of the accommodating structure 1740, between two of the outerflow-through features 1781, may comprise a thickened section providingfor the improved delivery function described above with respect to thethickened feature 1668.

In some embodiments, the standoffs 1755 may be bonded to the secondcomponent 1740 b, in alternate embodiments the standoffs 1755 may not bebonded to another component. In either case, the interaction of theskirt 1732 with the perimeter of the second optical component 1750 willminimize non-uniform deformations in one or both of the first and secondoptical components 1710 and 1750 originating at their outer peripheryand thereby reduce optical aberrations.

In some embodiments not shown the inner surfaces of the bellows region1708 of 1740 a and or 1740 b may comprise standoffs which constrainportions of the bellows from collapsing and forming a seal oncompression.

FIGS. 18A-18D illustrate an embodiment of an AIOL 1800 in accordancewith an embodiment of the present technology. FIGS. 18A-18D have thefollowing features.

-   -   1800 AIOL    -   1801 seam    -   1803 outer fluid reservoir    -   1803 a first bellows structure    -   1803 b second bellows structure    -   1805 fluid chamber    -   1808 bellows    -   1810 first optical component    -   1812 fluid accommodating lens    -   1820 passages    -   1830 fixed lens    -   1831 engagement feature    -   1832 skirt    -   1836 optical portion    -   1840 accommodating structure    -   1840 a first component    -   1840 b second component    -   1841 chamber    -   1850 second optical component    -   1851 square-shaped annular edge    -   1855 standoff    -   1857 recesses    -   1858 wall    -   1860 fluid fill thickened section    -   1868 lens engagement thickened region    -   1871 mid-bellows attachment feature    -   1873 mid-bellows channel    -   1881 outer flow-through features

FIGS. 18A-D illustrate an embodiment of an AIOL 1800 that includesdifferent channels for fluid to flow from the outer fluid reservoir tothe inner fluid chamber. Referring to FIG. 18B, the AIOL 1800 has anaccommodating structure 1840 having a first component 1840 a and thesecond component 1840 b. As described above, the first and secondcomponents 1840 a and 1840 b are assembled to form an outer fluidreservoir 1803, a mid-bellows channel 1873, and an inner fluid chamber1805. The first component 1840 a of the accommodating structure 1840 canhave an inner portion with a first optical component 1810, standoffs1855, and recesses 1857 between the standoffs 1855. The standoffs 1855project radially outward from the recesses 1857. The second component1840 b of the accommodating structure 1840 can have an inner portionwith a second optical component 1850 and a wall 1858. Referring to FIGS.18C and 18D, which are cross-sectional views taken along lines A-A andB-B of FIG. 18A, respectively, the standoffs 1855 contact the wall 1858(FIG. 18D) such that the recesses 1857 (FIG. 18B) define channels forfluid to flow from the mid-bellows channel 1873 to the fluid chamber1805.

The interface between the standoffs 1855 and the wall 1858 of theaccommodating structure 1840 are different than the interface betweenthe standoffs 1755 and the second optical component 1750 described abovewith reference to the AIOL 1700. More specifically, the standoffs 1855project radially outward to engage the wall 1858, whereas the standoffs1755 are within the optical region of the device and projectposteriorly. The standoffs 1855 of the AIOL 1800 accordingly do notextend into the optical region of the AIOL, which increases the field ofview of the AIOL 1800 compared to the AIOL 1700.

As with the AIOL 1700 described above, the AIOL 1800 includesflow-through features 1881 that enhance the rate and ease with whichOphthalmic Viscosurgical Devices (OVDs) used during the implantation ofAIOLs can be removed from the natural lens capsule. The embodiment ofthe AIOL 1800 illustrated in FIGS. 18A-18D comprises three outerflow-through features 1881. The outer flow-through features 1881 can bedetents, such as a recess, distributed circumferentially along theperimeter of the outer fluid reservoir 1803. In the illustratedembodiment, the flow-through features 1881 are formed in regions of thefirst and second components 1840 a and 1840 b. Although three outerflow-through features 1881 are illustrated, other embodiments maycomprise less or more than illustrated. The outer flow-through featuresmay additionally provide rotational constraint as described herein withregard to the AIOL of embodiment 1000.

The embodiment of the AIOL 1800 additionally comprises a fixed lensassembly 1830. The fixed lens assembly 1830 illustrated in FIGS. 18C-Dincludes an optical portion 1836, a skirt 1832 extending from theoptical portion 1836, and passages 1820. The optical portion 1836 has afixed power which may comprise an asymmetrically powered lens or otherlens as explained herein, and the passages 1820 are holes, slots,orifices, etc., that pass through the skirt 1832 and extend into aperimeter region but not the optical portion 1836.

Referring to FIG. 18C, the fixed lens assembly 1830 has an engagementfeature 1831, such as an annular groove, that extends around the skirt1832, and the first component 1840 a of the accommodating structure 1840has a thickened region 1868, such as an annular protrusion (e.g., aledge) that extends radially inwardly. The fixed lens assembly 1830 canbe attached to the accommodating structure 1840 by engaging thecontinuous thickened region 1868 of the first component 1840 a with theengagement feature 1831 of the fixed lens 1830. In other embodiments(not shown), the thickened region 1868 and the engagement feature 1831may be discontinuous features (e.g., segmented or other recesses orprotrusions that extend around less than the full circumference of thefixed lens assembly 1830 and the accommodating structure 1840). Such adiscontinuous thickened region 1868 and engagement feature 1831 aredesirable to maintain a particular radial alignment between the fixedlens assembly 1830 and the accommodating structure 1840, such as whenthe fixed lens 1830 comprises a toric lens or other asymmetrical lens.Alternatively, the groove may be in the fixed lens 1830 and theprotrusion on the accommodating structure 1840.

The AIOL 1800 has a fluid accommodating lens 1812 defined by a fluidchamber 1805 (FIGS. 18C and 18D) bounded between a first opticalcomponent 1810 and a second optical component 1850. The fluid chamber1805 is in fluid communication with the outer reservoir 1803 viadiscrete fluid channels 1849 between standoffs 1855 when the first andsecond components 1840 a and 1840 b are assembled. The first and secondoptical components 1810 and 1850 may be planar members (e.g., opticalmembranes) of the first and second components 1840 a and 1840 b,respectively. The first and second optical components 1810 and 1850, forexample, can be integrally formed as optical membranes with the otherportions of the first and second components 1840 a and 1840 b. Inalternate embodiments, either or both of the membranes of the first andsecond optical components 1810 and 1850 may be a lens (i.e., have anoptical power).

The AIOL 1800 can further include a square-shaped annular region 1851that inhibits cell migration from the periphery of the patient's capsuleto the optical part of AIOL 1800 (shown in FIGS. 18C-D at the posteriormost region of the lens). Such cell migration could cause post-surgeryopacification of the optical system.

The peripheral portions of the first component 1840 a and the secondcomponent 1840 b define the outer fluid reservoir 1803, and the innerportions of the first and second components 1840 a and 1840 b define theaccommodating structural element 1840. The first and second components1840 a and 1840 b can be bonded together at a seam 1801 by means asdescribed elsewhere herein. The first and second components 1840 a and1840 b can also be bonded at other areas, such as at the standoffs 1855.The standoffs 1855 are separated by spaces that define fluid channelsbetween the outer fluid reservoir 1803 and the inner fluid chamber 1805.The outer fluid reservoir 1803 can be a bellows 1808 having an outerbellows region 1803 a and an inner bellows region 1803 b, and the innerbellows region 1803 b can be defined by the channels between thestandoffs 1855.

The outer fluid reservoir 1803 has less volume than the outer fluidreservoirs of other AIOLs described herein, and in particular the volumeof the inner bellows region 1803 b is less than the outer bellows region1803 a. By reducing the volume of the inner bellows region 1803 b,additional space surrounding the optical region of the AIOL allows theoptical aperture of the fixed lens 1830 to be larger compared toembodiments with larger inner bellows regions. Additionally, thepassages 1820 of the fixed lens 1830, which allow aqueous fluid tofreely flow in and out of the chamber 1841, are configured to passthrough only the outer skirt 1832 and not the top optical portion 1836.This is expected to reduce unwanted scattered light from internalreflections which may pass through the optical system and reach theretina.

The first component 1840 a may also comprise one or more thickenedregions 1860 for use as described above with respect to, for instance,the thickened region 1860 of the AIOL 700 for use in filling the AIOLwith an optical fluid. The thickened region 1860 allows for a longerpath for a needle used to fill the accommodating structure with opticalfluid while a second needle in a different region is used to remove thegases the fluid is replacing. As illustrated, the fluid fill thickenedregion 1860 is located adjacent one or more of the outer fluidflow-throughs 1881.

Referring to FIG. 18D, the outer fluid reservoir 1803 of the AIOL 1800can comprise (a) a first bellows structure 1803 a with an anteriorportion 1804 a and a posterior portion 1804 b, (b) a second bellowsstructure 1803 b radially inward of the first bellows structure 1804 a,and (c) the mid-bellows channel structure 1873 defining a horizontalpassageway between the first and second bellows structures 1803 a and1803 b. During operation as the capsule contracts, a mid-portion of thefirst bellows structure 1803 a is constrained by the mid-bellows channel1873 while the anterior and posterior portions 1804 a and 1804 b of thefirst bellows structure 1803 a move radially inward with respect to themid-bellows channel 1873. The anterior and posterior portions 1804 a and1804 b of the first bellows structure 1803 a will accordingly flexradially inward to a greater extent than some other outer reservoirstructures described above (e.g., outer fluid reservoir 103 shown inFIG. 1) in response to the same amount of movement of the nativecapsule. This causes more fluid to flow from the outer fluid reservoir1803 to the inner fluid chamber 1805 and thereby provides moreaccommodation because anterior-posterior collapse of the outer fluidreservoir 1803 is less efficient than radial compression of the outerfluid reservoir 1803. Embodiments such as but not limited to any ofthose illustrated herein may be constructed from parts in which some orall of the portions not in the optical path XX have been dyed or treatedto reduce light throughout to limit the ability of stray light enteringportions outside the optical path from scattering into the optical pathYY as indicated in FIG. 9B.

The fixed lens described in any of the embodiments described herein maybe of spheric, aspheric, toric, or any other known lens configuration.Alternatively, or in combination, the fixed solid lens may beplano-convex, convex-concave, or convex-convex. The fixed lens may beconfigured to have positive or have negative fixed power.

The fluid lenses described herein may be configured such as to have oneor more accommodating surfaces, for example two accommodating surfaces.

In some embodiments, the optical fluid may be comprised of a highrefractive index poly vinyl alcohol.

In some embodiments, instead of membranes without a power, theaccommodating structure can include one or more deformable lenses thatdeflect based upon fluid pressure within the inner fluid chamber. Thedeformable lenses can each or both have a fixed power that can bepositive or negative.

The multipart AIOL devices described herein may be implanted bypreparing the eye and removing the native lens from the capsule in anyappropriate manner. The fluid-filled structure may then be placed in thecapsule of the eye. The patient may then be evaluated for a base opticalpower and/or astigmatic correction, and a fixed lens is selected toprovide the desired based power or astigmatic correction for thefluid-filled structure in the implanted state in the capsule of the eye.The specific fixed lens to provide the post-implant base power orastigmatic correction is then inserted into the previously implantedfluid-filled structure of the AIOL. The chosen fixed lens may then becoupled to the fluid-filled structure within the eye capsule. This ispossible in the AIOLs of the present technology because the fixed lensesare attached to the anterior first component of the AIOLs. As describedabove, one or more of the fluid-filled accommodating structure or fixedlens may each be flexible such that they may be reconfigured (e.g.,folded) to a reduced-profile delivery configuration for delivery intothe lens capsule. In some instances, it may be required to make afurther correction to the fixed portion after the time of the surgery.Such instance may occur anywhere from days to years after the surgery.At such times, the patient may return to the physician and the fixedlens may be replaced with a new fixed lens having a different opticalpower or other prescription. In such instances, the new prescription maybe characterized prior to or after removal of the original fixed lens.In some instances, the new fixed lens may be fabricated and implanted atthe time of the examination, in others the patient may return forimplantation of the fixed lens sometime after the examination.

Several embodiments of the present technology are directed to a kithaving an accommodating structure and a first fixed lens that has nooptical base power. The kit can further include one or more second fixedlenses having various based powers or other optical properties. Inpractice, the accommodating structure can be implanted into the nativeeye capsule, and then the first fixed lens can be coupled to theaccommodating structure. The optical properties of the implantedaccommodating structure can then be assessed in situ with the firstfixed lens in place to determine the desired optical properties of thefixed lens. If the optical properties of the assembled accommodatingstructure and first fixed lens without a base power are appropriate,then the system can remain implanted without additional changes.However, if a different base power or some other optical property isdesired (e.g., toric or other asymmetrical optics), then the first fixedlens without a base power can be replaced with a second fixed lenshaving the desired optical properties based on the optical properties ofthe implanted accommodating portion with a fixed lens attached.

In some embodiments, the fixed portion of the AIOL may be fabricatedfrom materials different from the accommodating portion. Such materialsinclude hydrophilic or hydrophobic methacrylate or silicones and anyother materials traditionally used in non-accommodating IOLs. The fixedlens may be fabricated from materials harder than those used for theaccommodating portion.

Any of the features of the intraocular lens systems described herein maybe combined with any of the features of the other intraocular lensesdescribed herein and vice versa. Additionally, several specific examplesof embodiments in accordance with the present technology are set forthbelow in the following examples.

EXAMPLES

1. An accommodating intraocular lens system, comprising:

-   -   an accommodating structure including a first optical component,        a second optical component posterior of the first optical        component, an inner fluid chamber between the first and second        optical components, and an outer fluid reservoir fluidically        coupled to the inner fluid chamber, wherein the outer fluid        reservoir is around at least a portion of the inner fluid        chamber and configured to interface with a native eye capsule        such that fluid flows between the outer fluid reservoir and the        inner fluid chamber to move the first optical element for        providing accommodation; and    -   a fixed lens configured to be detachably coupled to the        accommodating structure such that the fixed lens is anterior of        the first optical component, wherein the fixed lens has a fixed        optical power.

2. The accommodating intraocular lens system of example 1 wherein thefixed lens comprises an optical portion and skirt projecting from theoptical portion.

3. The accommodating intraocular lens system of example 2 wherein theskirt comprises an annular wall projecting posteriorly from the opticalportion.

4. The accommodating intraocular lens system of example 3 wherein theskirt flares radially outward posteriorly from the optical portion.

5. The accommodating intraocular lens system of any of examples 3-4wherein the fixed lens further comprises a passage through the skirt.

6. The accommodating intraocular lens system of any of examples 3-5wherein the fixed lens further comprises a passage extending laterallythrough the skirt, and wherein the passage does not extend through theoptical portion.

7. The accommodating intraocular lens system of any of examples 3-6wherein the fixed lens comprises a passage.

8. The accommodating intraocular lens system of any of examples 1-7wherein the fixed lens has a positive optical power.

9. The accommodating intraocular lens system of any of examples 1-7,wherein the fixed lens has a negative optical power.

10. The accommodating intraocular lens system of any of examples 1-7wherein the optical power of the fixed lens is zero.

11. The accommodating intraocular lens system of any of examples 1-10wherein the fixed lens comprises an asymmetric lens.

12. The accommodating intraocular lens system of any of examples 1-11wherein the optical structure has an anterior component and a posteriorcomponent, the anterior component including the first optical componentand a first peripheral region around the first optical component, theposterior component including the second optical component and a secondperipheral region around the second optical component, and wherein thefirst peripheral region is attached to the second peripheral regionalong a seam such that the first and second peripheral regions definethe outer fluid reservoir.

13. The accommodating intraocular lens system of example 12 wherein theouter fluid reservoir comprises a first bellows structure, a secondbellows structure radially inward of the first bellows structure, and amid-bellows channel structure between the first and second bellowsstructures, and wherein the mid-bellows channel structure includes atransverse portion and the first bellows structure has an anteriorportion projecting anteriorly from the transverse portion and aposterior portion projecting posteriorly from the transverse portion.

14. The accommodating intraocular lens system of example 13 wherein theanterior and posterior portions of the first bellows structure areconfigured to flex radially inwardly with respect to an outer-mostsection of the transverse portion in operation.

15. The accommodating structure of any of examples 12-14 wherein atleast one of the anterior portion or the posterior portion comprisesstandoffs between the inner fluid chamber and the outer fluid reservoir,the standoffs defining channels therebetween for fluid to flow betweenthe inner fluid chamber and the outer fluid reservoir.

16. The accommodating structure of example 15 wherein at least a portionof the standoffs are bonded to the other of the anterior portion or theposterior portion.

17. The accommodating intraocular lens system of any of examples 1-16,further comprising a cell dam posterior of a posterior-most portion ofthe outer fluid reservoir.

18. The accommodating intraocular lens system of any of examples 1-11wherein the outer fluid reservoir comprises a first bellows structurehaving an anterior portion and a posterior portion, a second bellowsstructure radially inward of the first bellows structure, and amid-bellows channel structure defined by a horizontal passageway betweenthe first and second bellows structures, and wherein a mid-portion ofthe first bellows structure is constrained by the mid-bellows channelstructure such that the anterior and posterior portions of the firstbellows structure move radially inward with respect to the mid-bellowschannel in operation.

19. The accommodating intraocular lens system of any of examples 1-18wherein the outer fluid reservoir has radial inward recesses that defineouter flow through features.

20. The accommodating intraocular lens system of any of examples 1-19,further comprising at least one thickened portion defining a path for aneedle used to fill the accommodating structure with optical fluid.

21. An accommodating intraocular lens system, comprising:

-   -   an accommodating structure having an anterior portion and a        posterior portion relative to a reference frame of a native eye,        the anterior portion and posterior portion defining (a) an        optical structure having inner fluid chamber and (b) an outer        fluid reservoir, wherein the outer fluid reservoir is configured        to interface with a native eye capsule such that fluid flows        between the outer fluid reservoir and the inner fluid chamber to        change the shape of the optical structure; and    -   a fixed lens having a fixed optical power, wherein the fixed        lens is configured to be coupled to and detached from the        anterior portion of the accommodating structure while the        accommodating structure is implanted in a native eye capsule.

22. The accommodating intraocular lens system of example 21 wherein thefixed lens comprises an optical portion and skirt projecting from theoptical portion.

23. The accommodating intraocular lens system of example 22 wherein theskirt comprises an annular wall projecting posteriorly from the opticalportion.

24. The accommodating intraocular lens system of example 23 wherein theskirt flares radially outward posteriorly from the optical portion.

25. The accommodating intraocular lens system of any of examples 22-24wherein the fixed lens further comprises a passage through the skirt.

26. The accommodating intraocular lens system of any of examples 22-24wherein the fixed lens further comprises a passage extending laterallythrough the skirt, and wherein the passage does not extend through theoptical portion.

27. The accommodating intraocular lens system of any of examples 22-24wherein the fixed lens comprises a passage.

28. The accommodating intraocular lens system of any of examples 21-27wherein the fixed lens has a positive optical power.

29. The accommodating intraocular lens system of any of examples 21-27,wherein the fixed lens has a negative optical power.

30. The accommodating intraocular lens system of any of examples 21-27wherein the optical power of the fixed lens is zero.

31. The accommodating intraocular lens system of any of examples 21-30wherein the fixed lens comprises an asymmetric lens.

32. The accommodating intraocular lens system of any of examples 21-31wherein:

-   -   the anterior portion of the accommodating structure includes a        first optical component and a first peripheral region around the        first optical component;    -   the posterior portion of the accommodating structure includes a        second optical component and a second peripheral region around        the second optical component; and    -   the first peripheral region is attached to the second peripheral        region along a seam such that the first and second peripheral        regions define the outer fluid reservoir.

33. The accommodating intraocular lens system of example 32 wherein theouter fluid reservoir comprises a first bellows structure, a secondbellows structure radially inward of the first bellows structure, and amid-bellows channel structure between the first and second bellowsstructures, and wherein the mid-bellows channel structure includes atransverse portion and the first bellows structure has (a) an anteriorportion projecting anteriorly from the transverse portion and (b) aposterior portion projecting posteriorly from the transverse portion.

34. The accommodating intraocular lens system of example 33 wherein theanterior and posterior portions of the first bellows structure areconfigured to flex radially inwardly with respect to an outer-mostsection of the transverse portion in operation.

35. The accommodating structure of example 32 wherein at least one ofthe anterior portion or the posterior portion of the accommodatingstructure comprises standoffs between the inner fluid chamber and theouter fluid reservoir, the standoffs defining channels therebetween forfluid to flow between the inner fluid chamber and the outer fluidreservoir.

36. The accommodating structure of example 35 wherein at least a portionof the standoffs are bonded to the other of the anterior portion or theposterior portion of the accommodating structure.

37. The accommodating intraocular lens system of any of examples 21-36,further comprising a cell dam posterior of a posterior-most portion ofthe outer fluid reservoir.

38. The accommodating intraocular lens system of any of examples 21-31wherein the outer fluid reservoir comprises a first bellows structurehaving an anterior portion and a posterior portion, a second bellowsstructure radially inward of the first bellows structure, and amid-bellows channel structure defined by a horizontal passageway betweenthe first and second bellows structures, and wherein a mid-portion ofthe first bellows structure is constrained by the mid-bellows channelstructure such that the anterior and posterior portions of the firstbellows structure move radially inward with respect to the mid-bellowschannel in operation.

39. The accommodating intraocular lens system of any of examples 21-38wherein the outer fluid reservoir has radial inward recesses that defineouter flow through features.

40. The accommodating intraocular lens system of any of examples 21-39,further comprising at least one thickened portion defining a path for aneedle used to fill the accommodating structure with optical fluid.

41. An accommodating intraocular lens system, comprising:

-   -   a kit including—        -   an accommodating structure including a first optical            component, a second optical component posterior of the first            optical component, an inner fluid chamber between the first            and second optical components, and an outer fluid reservoir            fluidically coupled to the inner fluid chamber, wherein the            outer fluid reservoir is around at least a portion of the            inner fluid chamber and configured to interface with a            native eye capsule such that fluid flows between the outer            fluid reservoir and the inner fluid chamber to move the            first optical element for providing accommodation; and        -   a first fixed lens configured to be detachably coupled to            the accommodating structure such that the first fixed lens            is anterior of the first optical component, wherein the            first fixed lens has no optical power; and    -   a second fixed lens configured to be detachably coupled to the        accommodating structure instead of the first fixed lens such        that the second fixed lens is anterior of the first optical        element, wherein the second fixed lens has an optical power.

42. The system of example 41 wherein the each of the first fixed lensand the second fixed lens comprises an optical portion and skirtprojecting from the optical portion.

43. The system of example 42 wherein the skirt comprises an annular wallprojecting posteriorly from the optical portion.

44. The system of example 43 wherein the skirt flares radially outwardposteriorly from the optical portion.

45. The system of any of examples 42-44 wherein each of the first fixedlens and the second fixed lens further comprises a passage extendinglaterally through the skirt, and wherein the passage does not extendthrough the optical portion.

46. The system of any of examples 41-45 wherein at least one of thefirst fixed lens or the second fixed lens comprises an asymmetric lens.

47. The system of any of examples 41-46 wherein the optical structurehas an anterior component and a posterior component, the anteriorcomponent including the first optical component and a first peripheralregion around the first optical component, the posterior componentincluding the second optical component and a second peripheral regionaround the second optical component, and wherein the first peripheralregion is attached to the second peripheral region along a seam suchthat the first and second peripheral regions define the outer fluidreservoir.

48. The system of example 47 wherein the outer fluid reservoir comprisesa first bellows structure, a second bellows structure radially inward ofthe first bellows structure, and a mid-bellows channel structure betweenthe first and second bellows structures, and wherein the mid-bellowschannel structure includes a transverse portion and the first bellowsstructure has an anterior portion projecting anteriorly from thetransverse portion and a posterior portion projecting posteriorly fromthe transverse portion.

49. The system of example 48 wherein the anterior and posterior portionsof the first bellows structure are configured to flex radially inwardlywith respect to an outer-most section of the transverse portion inoperation.

50. The system of example 47 wherein at least one of the anteriorportion or the posterior portion comprises standoffs between the innerfluid chamber and the outer fluid reservoir, the standoffs definingchannels therebetween for fluid to flow between the inner fluid chamberand the outer fluid reservoir.

51. The system of example 50 wherein at least a portion of the standoffsare bonded to the other of the anterior portion or the posteriorportion.

52. The accommodating intraocular lens system of any of examples 41-51,further comprising a cell dam posterior of a posterior-most portion ofthe outer fluid reservoir.

53. The system of any of examples 41-46 wherein the outer fluidreservoir comprises a first bellows structure having an anterior portionand a posterior portion, a second bellows structure radially inward ofthe first bellows structure, and a mid-bellows channel structure definedby a horizontal passageway between the first and second bellowsstructures, and wherein a mid-portion of the first bellows structure isconstrained by the mid-bellows channel structure such that the anteriorand posterior portions of the first bellows structure move radiallyinward with respect to the mid-bellows channel in operation.

54. The system of any of examples 41-53 wherein the outer fluidreservoir has radial inward recesses that define outer flow throughfeatures.

55. The system of any of examples 41-54, further comprising at least onethickened portion defining a path for a needle used to fill theaccommodating structure with optical fluid.

56. A method of implementing an accommodating intraocular lens system,comprising:

-   -   implanting an accommodating structure into a native eye capsule,        wherein the accommodating structure has a first optical        component, a second optical component posterior of the first        optical component, an inner fluid chamber between the first and        second optical components, and an outer fluid reservoir        fluidically coupled to the inner fluid chamber;    -   coupling a fixed lens to the accommodating structure after        implanting the accommodating structure in the native eye        capsule.

57. The method of example 56 wherein the fixed lens comprises a firstfixed lens, and the method further comprises (a) detaching the firstfixed lens from the accommodating structure and (b) attaching a secondfixed lens to the accommodating structure, and wherein the second fixedlens has a different optical power than the first fixed lens.

58. The method of any of examples 56-57 wherein the fixed lens comprisesan optical portion and a skirt projecting posteriorly from the opticalportion such that an aqueous chamber is formed between the opticalportion of the fixed lens and the first optical component of theaccommodating structure when the fixed lens is coupled to theaccommodating structure.

59. The method of any of examples 56-58 wherein the first opticalcomponent is part of an anterior component and the second opticalcomponent is part of a posterior component, and the method comprisescoupling and fluidically sealing the anterior and posterior componentstogether before implanting the accommodating structure.

60. The method of example 59 wherein the anterior and posteriorcomponents are coupled and fluidically sealed together in a dry state,and further comprising hydrating the coupled and fluidically sealedanterior and posterior components before implanting the accommodatingstructure.

61. The method of any of examples 56-60 wherein the accommodatingstructure has an index mark and the method further comprises rotatingthe fixed lens based on the index mark on the accommodating structure.

62. The method of example 61 wherein the fixed lens has physical featureand the process of rotating the fixed lens comprises registering thephysical feature of the fixed lens with respect to the index mark on theaccommodating structure.

63. The method of example 56 wherein the fixed lens comprises a firstfixed lens, and wherein the method further comprises:

-   -   assessing whether the implanted accommodating structure with the        first fixed lens coupled to the accommodating structure in the        eye provides a desired accommodation; and    -   replacing the first fixed lens with a second fixed lens having a        different base power when the assessed accommodation is        different than the desired accommodation.

While preferred embodiments of the present disclosure have been shownand described herein, it will be obvious to those skilled in the artthat such embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the disclosure describedherein may be employed in practicing the disclosure.

What is claimed is:
 1. An accommodating intraocular lens system,comprising: an accommodating structure including a first opticalcomponent, a second optical component posterior of the first opticalcomponent, an inner fluid chamber between the first and the secondoptical components, and an outer fluid reservoir fluidically coupled tothe inner fluid chamber, wherein the outer fluid reservoir is around atleast a portion of the inner fluid chamber and comprises an outer wallconfigured to interface with and contact a native eye capsule such thata fluid flows between the outer fluid reservoir and the inner fluidchamber to move the first optical component for providing accommodation;and a fixed lens configured to be detachably coupled to theaccommodating structure when operable and within the native eye capsulesuch that the fixed lens is anterior of the first optical component,wherein the fixed lens has a fixed optical power.
 2. The accommodatingintraocular lens system of claim 1 wherein the fixed lens comprises anoptical portion and a skirt projecting from the optical portion, and theskirt comprises an annular wall projecting posteriorly from the opticalportion.
 3. The accommodating intraocular lens system of claim 2 whereinthe fixed lens further comprises a passage extending laterally throughthe skirt, and wherein the passage does not extend through the opticalportion.
 4. The accommodating intraocular lens system of claim 1 whereinthe outer fluid reservoir comprises a first bellows structure, a secondbellows structure radially inward of the first bellows structure, and amid-bellows channel structure between the first and the second bellowsstructures, and wherein the mid-bellows channel structure includes atransverse portion and the first bellows structure has an anteriorportion projecting anteriorly from the transverse portion and aposterior portion projecting posteriorly from the transverse portion. 5.The accommodating intraocular lens system of claim 4 wherein theanterior and the posterior portions of the first bellows structure areconfigured to flex radially inwardly with respect to an outer-mostsection of the transverse portion in operation.
 6. The accommodatingstructure of claim 4 wherein at least one of the anterior portion or theposterior portion comprises standoffs between the inner fluid chamberand the outer fluid reservoir, the standoffs defining channelstherebetween for the fluid to flow between the inner fluid chamber andthe outer fluid reservoir.
 7. The accommodating structure of claim 1,further comprising a plurality of attachment features radially inwardfrom a seam and located between the first and the second opticalcomponents.
 8. The accommodating intraocular lens system of claim 1wherein the outer fluid reservoir comprises a first bellows structurehaving an anterior portion and a posterior portion, a second bellowsstructure radially inward of the first bellows structure, and amid-bellows channel structure defined by a horizontal passageway betweenthe first and the second bellows structures, and wherein a mid-portionof the first bellows structure is constrained by the mid-bellows channelstructure such that the anterior and the posterior portions of the firstbellows structure move radially inward with respect to the mid-bellowschannel in operation.
 9. An accommodating intraocular lens system,comprising: an accommodating structure having an anterior portion and aposterior portion relative to a reference frame of a native eye, theanterior portion and the posterior portion defining (a) an opticalstructure having an inner fluid chamber and (b) an outer fluidreservoir, wherein the outer fluid reservoir includes an outer wallconfigured to contact a native eye capsule, and wherein the outer fluidreservoir is configured to interface with the native eye capsule suchthat fluid flows between the outer fluid reservoir and the inner fluidchamber to change the shape of the optical structure; and a fixed lenshaving a fixed optical power, wherein the fixed lens is configured to becoupled to and detached from the anterior portion of the accommodatingstructure while the accommodating structure is operable and within thenative eye capsule.
 10. The accommodating intraocular lens system ofclaim 9 wherein the fixed lens comprises an optical portion and a skirtprojecting from the optical portion, and the skirt comprises an annularwall projecting posteriorly from the optical portion.
 11. Theaccommodating intraocular lens system of claim 10 wherein the fixed lensfurther comprises a passage extending laterally through the skirt, andwherein the passage does not extend through the optical portion.
 12. Theaccommodating intraocular lens system of claim 9 wherein the outer fluidreservoir comprises a first bellows structure, a second bellowsstructure radially inward of the first bellows structure, and amid-bellows channel structure between the first and the second bellowsstructures, and wherein the mid-bellows channel structure includes atransverse portion and the first bellows structure has (a) an anteriorportion projecting anteriorly from the transverse portion and (b) aposterior portion projecting posteriorly from the transverse portion.13. The accommodating intraocular lens system of claim 12 wherein theanterior and the posterior portions of the first bellows structure areconfigured to flex radially inwardly with respect to an outer-mostsection of the transverse portion in operation.
 14. The accommodatingstructure of claim 9 wherein at least one of the anterior portion or theposterior portion of the accommodating structure comprises standoffsbetween the inner fluid chamber and the outer fluid reservoir, thestandoffs defining channels therebetween for the fluid to flow betweenthe inner fluid chamber and the outer fluid reservoir.
 15. Theaccommodating structure of claim 14 wherein at least a portion of thestandoffs are bonded to the other of the anterior portion or theposterior portion of the accommodating structure.
 16. The accommodatingintraocular lens system of claim 9 wherein the outer fluid reservoircomprises a first bellows structure having an anterior portion and aposterior portion, a second bellows structure radially inward of thefirst bellows structure, and a mid-bellows channel structure defined bya horizontal passageway between the first and the second bellowsstructures, and wherein a mid-portion of the first bellows structure isconstrained by the mid-bellows channel structure such that the anteriorand the posterior portions of the first bellows structure move radiallyinward with respect to the mid-bellows channel in operation.
 17. Anaccommodating intraocular lens system, comprising: an accommodatingstructure including a first optical component, a second opticalcomponent posterior of the first optical component, an inner fluidchamber between the first and the second optical components, and anouter fluid reservoir fluidically coupled to the inner fluid chamber,wherein the outer fluid reservoir is around at least a portion of theinner fluid chamber and comprises an outer wall configured to interfacewith and contact a native eye capsule such that a fluid flows betweenthe outer fluid reservoir and the inner fluid chamber to move the firstoptical component for providing accommodation; and a fixed lensconfigured to be detachably coupled to the accommodating structure suchthat the fixed lens is anterior of the first optical component, whereinthe fixed lens has a fixed optical power; wherein the outer fluidreservoir comprises a first bellows structure, a second bellowsstructure radially inward of the first bellows structure, and amid-bellows channel structure between the first and the second bellowsstructures, and wherein the mid-bellows channel structure includes atransverse portion and the first bellows structure has an anteriorportion projecting anteriorly from the transverse portion and aposterior portion projecting posteriorly from the transverse portion.18. An accommodating intraocular lens system, comprising: anaccommodating structure including a first optical component, a secondoptical component posterior of the first optical component, an innerfluid chamber between the first and the second optical components, andan outer fluid reservoir fluidically coupled to the inner fluid chamber,wherein the outer fluid reservoir is around at least a portion of theinner fluid chamber and comprises an outer wall configured to interfacewith and contact a native eye capsule such that a fluid flows betweenthe outer fluid reservoir and the inner fluid chamber to move the firstoptical component for providing accommodation; and a fixed lensconfigured to be detachably coupled to the accommodating structure suchthat the fixed lens is anterior of the first optical component, whereinthe fixed lens has a fixed optical power; wherein the outer fluidreservoir comprises a first bellows structure having an anterior portionand a posterior portion, a second bellows structure radially inward ofthe first bellows structure, and a mid-bellows channel structure definedby a horizontal passageway between the first and the second bellowsstructures, and wherein a mid-portion of the first bellows structure isconstrained by the mid-bellows channel structure such that the anteriorand the posterior portions of the first bellows structure move radiallyinward with respect to the mid-bellows channel in operation.
 19. Anaccommodating intraocular lens system, comprising: an accommodatingstructure having an anterior portion and a posterior portion relative toa reference frame of a native eye, the anterior portion and theposterior portion defining (a) an optical structure having an innerfluid chamber and (b) an outer fluid reservoir, wherein the outer fluidreservoir includes an outer wall configured to contact a native eyecapsule, and wherein the outer fluid reservoir is configured tointerface with the native eye capsule such that fluid flows between theouter fluid reservoir and the inner fluid chamber to change the shape ofthe optical structure; and a fixed lens having a fixed optical power,wherein the fixed lens is configured to be coupled to and detached fromthe anterior portion of the accommodating structure while theaccommodating structure is implanted in the native eye capsule; whereinthe outer fluid reservoir comprises a first bellows structure, a secondbellows structure radially inward of the first bellows structure, and amid-bellows channel structure between the first and the second bellowsstructures, and wherein the mid-bellows channel structure includes atransverse portion and the first bellows structure has (a) an anteriorportion projecting anteriorly from the transverse portion and (b) aposterior portion projecting posteriorly from the transverse portion.20. An accommodating intraocular lens system, comprising: anaccommodating structure having an anterior portion and a posteriorportion relative to a reference frame of a native eye, the anteriorportion and the posterior portion defining (a) an optical structurehaving an inner fluid chamber and (b) an outer fluid reservoir, whereinthe outer fluid reservoir includes an outer wall configured to contact anative eye capsule, and wherein the outer fluid reservoir is configuredto interface with the native eye capsule such that fluid flows betweenthe outer fluid reservoir and the inner fluid chamber to change theshape of the optical structure; and a fixed lens having a fixed opticalpower, wherein the fixed lens is configured to be coupled to anddetached from the anterior portion of the accommodating structure whilethe accommodating structure is implanted in the native eye capsule;wherein the outer fluid reservoir comprises a first bellows structurehaving an anterior portion and a posterior portion, a second bellowsstructure radially inward of the first bellows structure, and amid-bellows channel structure defined by a horizontal passageway betweenthe first and the second bellows structures, and wherein a mid-portionof the first bellows structure is constrained by the mid-bellows channelstructure such that the anterior and the posterior portions of the firstbellows structure move radially inward with respect to the mid-bellowschannel in operation.